PSAIRISH PHARMACEUTICAL STUDENTS’ ASSOCIATION

Feb, 2015Issue 3

IN THIS EDITION

Life as an intern: three recent graduates recount their experience of their MPharm year

Professional Career Profile: Industry and regulatory special

Life in the southern states: exchange with BillGatton College, Tennessee, USA

Thank you for attending the IPSA weekend!Photo: Áras na Mac Léinn, UCC, Cork

22 Issue 3, Volume 1 | Feb 2015

LIFE AS AN INTERNWhat to expect in your MPharm year

The M. Pharm year is both an exciting and nerve wrecking year between being a graduate with a bach-elor of pharmacy degree yet still not a fully fledged pharmacist! It’s a year where you begin applying all the pharmacy goodness you have learned from studying clinical, pharmaceutics and pharmacology

for four years and putting that knowledge in to practice. For many students, the option of working in avenues other than the traditional community pharmacy route is worth exploring. For anyone interested in doing so in the future we wanted to help uncover any mysteries that such a placement would have for undergraduate students, to do this, we decided to interview three recent graduates of the MPharm class of 2013/14 to give us the low down on their own personal experience of the year. Our three interviewees are Sadhbh who graduat-ed from University College Cork in 2013 work undertook a 12 month placement in Cork University Hospital; our second interviewee is Martin Lanigan derived from the Royal College of Surgeons and our final inter-viewee Niamh Lloyd of Trinity College. Both Martin and Niamh both took a twelve month split placement between Industry and Community. We would like to personally thank Sadhbh, Martin and Niamh for taking time out of their busy schedule to answer these questions and we wish them the best in their future careers.

Sadhbh Ní CheallaighUCC Graduate (2013)

12 month hospital placement

Could you give us a brief overview of your year, what area did you work in? How did you find it?I completed my pharmacy internship in Cork Uni-versity Hospital. Honestly I couldn’t have asked for a better placement. It was a great environment to work and to learn in. It was challenging but the rest of the pharmacy staff gave me great support so I never felt out of my depth. Working in a large teaching hospital, I got to see such a huge variety of specialties, from the general wards to more specialised areas like neonatal, paediatrics, maternity, oncology and intensive care. Overall I would say the year was a brilliant experience.

What tasks would your typical week involve?I followed a structured rota during the year, which would be similar in most hospital placements. I start-ed off working as a technician in the dispensary and doing ward stock top ups. This allowed me to get to know my environment, become familiar with how everything worked and the various roles everyone had. After Christmas I did four weeks in medicines information, where pharmacists would pass on que-ries they had come across that required a bit more re-search. This could involve anything from investigating

unusual side effects to determining whether particular medicines were suitable for coeliacs. The main thing you learn from that type of work is generally how best to source information when you need it, as the queries that you do are sometimes so obscure that you would never need the information again! Following that ro-tation I was paired with each of the pharmacists for two week slots. During this time I would shadow the pharmacist on the ward they were covering and they would also give me reading material on their particu-lar specialty. I learned a lot of practical information from this rotation and this helped me prepare for the

by Jason Hayes, Vice-President

3Issue 3, Volume 1 | Feb 2015

next stage where I was given my own ward to cover. It was a cardiology and haematology ward so there was a mixture of patients, some very straightforward and some very complex. It’s definitely scary being respon-sible for your own ward for the first time but there was always another pharmacist on one of the wards nearby so I was never completely alone. My last rota-tion was in aseptics in the chemotherapy compound-ing unit. This was a completely different experience and I actually really enjoyed it. It’s a very structured and controlled environment so you know what to ex-pect from your day. Outside of aseptics, my days were unpredictable and varied, which keeps things exciting and challenging.

What do you feel are the most challenging and most enjoyable aspects of the year?The most enjoyable part of the year was learning lots of new information and seeing my own progress from a pharmacy student to a pharmacist. I gained so much knowledge and confidence during the course of the year and met some fantastic people. The biggest challenge was definitely time management. Working, studying, doing assignments and a thesis is very diffi-cult and we all struggled around the deadlines. You have to give up a lot of your free time to get things done which is hard because you don’t get a good work/life balance. Though it was hard at the time, we all managed to get everything done in the end and once you finish the intern year you get your evenings and weekends back which I’m really enjoying at the moment!

If you could give advice to a student who was inter-ested in going down a similar direction to you, what advice would you give?I would encourage anyone who is interested to pur-sue hospital pharmacy, it really is a great area to work in. It is quite competitive but don’t let that put you off. Each employer is looking for something different; some want a student with top marks, others look for a specific personality type that will fit well with the team, often it’s a combination of both. Just be yourself at the interviews, and don’t panic if you don’t get of-fered the first few you go for.

How did you find the academic demands of the MPharm, keeping up with coursework, the disserta-tion and so on?As I mentioned above, this was definitely the most challenging part of the year. The thesis in particular

was very demanding. I was lucky that I was allowed time at work to do my project and assignments if I was struggling with a deadline, but most work places can’t give you that time. What I would advise is to make sure you let your tutor and lecturers know if you are struggling with a deadline, because they can only help if you tell them.

How did you find the final exam in RCSI? Any tips for future students?The final exam was definitely stressful, as all exams are. The format of the exam is changing next year to include more OSCE stations and less MCQs. The most important thing for the OSCE is to stay calm. You can study for it and you should study as much as you can, but what you will find is that what you learn from your workplace during the year in terms of clinical knowledge and communication skills is the best thing you can bring to the exam. Eat well, drink enough water and stay away from people that will make you panic. The time flies so make the most of each station, use the reading material if you need it but if you feel confident then don’t waste time on it. In terms of calculations, it’s all practice. Get together in groups and run through the sample questions togeth-er. If you have a basic method set out for each type of problem you can apply it to any question in the exam no matter how complicated it looks when you read it. And don’t forget your calculator…

What do you think of CAASP?I think it’s an improvement on the old system. When I was applying for positions, I had no idea when the ones I was interested were going to be advertised, or if they were even going to advertise at all. Also, the in-terviews were very close to the exams so we lost study days and that added to the stress. It would have been easy to panic and take the first thing you were offered, even if it wasn’t what you wanted, for fear of not get-ting any other offers. I was lucky that I got what I wanted early, but it didn’t work out that way for ev-eryone. The new central application process will stan-dardise everything and should definitely make things easier for the students. Everything will be done and dusted within a specific time frame and you can get your placement sorted and concentrate on the exams.

4 Issue 3, Volume 1 | Feb 2015

Martin LaniganRCSI Graduate (2013)

Split industry/community placement

Could you give us a brief overview of the 6 months you spent working in the pharmaceutical industry as part of your M.Pharm programme; what area did you work in? How did you find it?I did my 6-month M.Pharm internship in the Global Chemistry and Manufacturing Control (CMC) regu-latory affairs department in Pfizer, based in their bio-technology plant in Grange Castle. I was working on the team that looked after the product Enbrel (etaner-cept), a fusion protein used in the treatment of Rheu-matoid Arthritis and other inflammatory disorders. CMC Regulatory affairs only handles the information contained within the Module 3 (Quality section) of the Common Technical Dossier (CTD). Our role was to ensure the manufacturing process used for Enbrel was recorded and up to date in the drug license for all registered markets (around 90). At first, working for such a large company and in an area that was com-pletely removed from community pharmacy, I found it a bit daunting. However after a few weeks I had set-tled in better and I really enjoyed working in this de-partment. Pfizer were very good for training and en-sured that I got to experience all the different aspects of pharmaceutical industry, including day trips to the affiliate office in Citywest and the oral tablet manufac-turing plant in Newbridge. This was invaluable for me to make informed decisions on where I would like to see my career head.

What tasks would your typical week involve?Normally I would start off the week with a look ahead to the projects that I was working on and this would help me determine what action points needed to be done based on what stage each particular project was at. Typically I would be working on many projects at one time. Most of the work was focused on providing a regulatory strategy; which meant that for proposed and upcoming manufacturing and quality changes, for all 90 markets we would need to determine the post-approval variation filing procedure, the review times for each market and when the market must be supplied with product incorporating the newly ap-proved changed. This involved a lot of meeting work with colleagues outside our department such as proj-ect teams, other regulatory groups, quality assurance, supply and of course the markets themselves. All in-formation would then have to be documented and

presented to appropriate teams.

What do you feel are the most challenging and most enjoyable aspects of the year?The most enjoyable aspect was communicating with all the different markets and getting a real under-standing of the global side to the pharmaceutical in-dustry. The most challenging aspect was getting used to speaking and understanding all the acronyms!!

If you could give advice to a student who was inter-ested in going down a similar direction to you, what advice would you give?I would really advise doing a split placement and it gives you a great insight into working in the industry. Unfortunately there are not many industrial places and so competition can be high. I really recommend doing background research on the company you are applying for, knowing the type of role on offer and the products you will work with.

How did you find the academic demands of the M.Pharm, keeping up with coursework, the dissertation and so on?Doing a split placement is more difficult than doing the regular 12-month internship. At times, in the in-dustry placement, I found a lot of the coursework ir-relevant to what I was doing during the day but when I was doing my community placement it made more sense! I kept up to date with the coursework and I really think that was the key to success in the pro-gramme. If you let the work build up then it will only lead to unnecessary stress! All it takes is just an hour or two in the evening every 2nd or 3rd day to stay on

5Issue 3, Volume 1 | Feb 2015

top of things and the odd weekend in Mercer library! How did you find the final exam in RCSI? Any tips for future students?I found the final exam very draining! The day is very long and so it is important to be as prepared as you can for it. You’ll need to bring a few study items but it can be hard to focus so just have short to-the-point notes for quick revision. Avoid the post exam analysis during the lunch break and focus on the exam ahead.

What do you think of the new centralised application system?It seems like a good idea to have it all through the one application as there was a lot of time wasted each year handing out CVs. It will be interesting to see if it works and how they will capture the placements that only come on board later in the year (i.e. most hospi-tal and industry placements).

Niamh LloydTCD Graduate (2013)

Split industry/community placement

Could you give us a brief overview of your year, what area did you work in? How did you find it?I really wanted to see what industrial pharmacy entailed and so opted for a split placement. I carried out my initial six months with GSK in regulatory affairs as a compliance executive and the latter half in a community pharmacy. I really loved working in industry. Although it’s a completely different role to that of a clinical pharmacist, I found I did use a lot of the skills and pharmaceutical knowledge I learned in

college which I feel is important. What tasks would your typical week involve?A typical week covers 9-5, Monday to Friday, which is something I didn’t truly appreciate enough at the time! The industry work was so varied, which is one thing that really appealed to me. I served primarily as an interface between the company and the external regulatory bodies, essentially maintaining the prod-uct licences in accordance with HPRA regulation. My job also included organising applications for sale of the products in foreign markets, giving scientific training relating to the different medications to new sales reps and maintenance of internal and external databases, including medicines.ie. The work is fast paced, you are continually working to deadlines and with several different individuals and teams and so communication skills are essential.

What do you feel are the most challenging and most enjoyable aspects of the year?For me the most challenging aspect of the year was definitely the shorter amount of time I spent in the clinical setting in comparison to most other in-terns. Unfortunately, the PRE is very much clinically focussed. There were days in the latter half of the internship that I did feel under pressure to try to take in as much as possible in preparation for the exam. That said it did all come together in the end and I really don’t feel the split placement had any negative impact on my results. The year definitely isn’t the easiest in the pharmacy course but it’s a good feeling to finally put what you’ve been learning into practice. It’s also you’re last year as a student so make the most of it before you have to start signing the register!

If you could give advice to a student who was inter-ested in going down a similar direction to you, what advice would you give?I would definitely recommend doing a split place-ment if you’re considering a path less chosen in the profession. It’s a niche area and there is competition other than pharmacists for the jobs so the experience really does stand to you afterwards. I would also encourage you to get involved in any pharmacy relat-ed committees/groups during your undergraduate. Showing initiative and interest outside of the course will set you apart from other candidates.

How did you find the academic demands of the MPharm, keeping up with coursework, the disserta-tion and so on?Balancing a full time job with the workload of the masters was difficult at times (especially towards the

6 Issue 3, Volume 1 | Feb 2015

EDITOR

Kyle Malone

LAYOUT & DESIGN

Mena Eskander

CONTRIBUTORS

Jason Hayes

Fiona Mannion

SPECIAL THANKSSadhbh Ní Cheallaigh, Martin Lanigan, Niamh Lloyd, Niall O’Shea, Rachel Bowes, Michael Lennon

This publication is the responsibility of the Irish Pharmaceutical Students’ Association.

PERSONNEL

end of the year) but was still manageable. I thought RCSI were conscientious to student needs in their deadlines and workload assignment.

How did you find the final exam in RCSI? Any tips for future students?The PRE was definitely tough but I think the best tip I can give is to keep your head under pressure especial-ly during the OSCE stations. The mock OSCE is based on past exams so try not to have looked at all the past papers before you go in. I think it’s important to use the mock as an accurate baseline to see what areas are your weakest areas are.

What do you think of CAASP?I think it’s a good idea; it seems like a fairer and less stressful way of sorting out the internship year for both interns and tutors. Hopefully it willl alleviate some of the pressure of the pre-registration year.

Exchange with Tennessee, USA

by Fiona Mannion, RCSI

Tara and I are both 4th year pharmacy students at-tending the Royal College of Surgeons in Ireland. As part of our final year project we were fortunate enough to be offered the opportunity to spend four weeks at the Bill Gatton College of Pharmacy in East Tennessee State University. During this time we were immersed in what pharmacy in Tennessee had to of-fer. We spent some time with students in the college attending lectures, as well as going on rotations with some of the final year students. These rotations (nine in total over a twelve month period) allowed the stu-dents to experience the different roles and settings in which pharmacists can be found, helping the students discover the type of pharmacist they ultimately would like to become. This idea of allowing students to ex-perience all types of pharmacy is a concept that will

now be integrated here in Ireland into the new five year pharmacy programme which begins with the 2016 intake of students – a welcomed change to the current course. We also had an opportunity to sit in on an American Pharmacists Association – Academy of Student Pharmacists meeting and were able to see the power and responsibility this student body group have in pushing pharmacy forward.We were exposed to many different aspects of phar-macy on our trip: community, clinical and ambulatory care. The majority of our time was spent in the ambu-latory care setting which we were very excited about as this was something neither Tara nor I had much ex-perience or knowledge of. Within these settings phar-macists manage their patients under a collaborative agreement which allows pharmacists to initiate, mod-ify or discontinue medications. We could see that by working under these collaborative agreements each member of the team (pharmacist, doctors, nurses, so-cial workers etc.) were encouraged to use their unique skill set to ensure better patient outcomes.Our time in Bill Gatton College of Pharmacy was an incredible experience and one that we are both so glad we took part in. We hope that the relationship between the two Colleges continues to grow and look forward to our visit from the students of Bill Gatton College of Pharmacy in the coming months.

Fiona Mannion and Tara McEnteggart

Issue 3, Volume 1 | Feb 2015

Pharmaceutical industry & regulatorsProfessional Career Profiles

Regulatory affairs is an exciting and dynamic field for pharmacists to work in requiring scientific knowledge and many skills. Many students may hear or even have an interest in perusing such a career in the future. This month, we interviewed three pharmacists working in Regulatory affairs to

illustrate what it takes to work in the field! We have two from a pharmaceutical company and one in contrast working for the Health Product Regulatory Authority (HPRA). We hope you will find this an interested read! We would like to thank each for taking part.

Rachel BoweLeo Pharma A/S

What tasks would a typical week involve? And how does this differ to regulatory career within the Health Product Regulatory Authority (HPRA)?There is no such thing as a typical week! Regulatory affairs within an affiliate is a key support function, and tasks would involve providing advice to colleagues, interaction with the health authorities (HPRA and MHRA) and industry groups, submission of varia-tions (e.g. labelling, manufacturing), project work, marketing compliance review and revision of SOPs.I feel that a key difference between this regulatory role and a career at the HPRA is the aspect of commercial enterprise within a pharmaceutical company as op-posed to a state agency.

What kind of person do you think this career would suit?Regulatory affairs at a sales and marketing affiliate would suit a commercially orientated person with a strong attention for detail.

What do you feel are the most challenging and most enjoyable aspects of your job?The most enjoyable aspect of my job is also the most challenging – working with sales and marketing col-leagues on promotional and educational materials. We frequently face challenges delivering an impactful and memorable promotional campaign or patient support programme within the parameters of legislation and codes of practice. However, it often forces me to find a solution through creative thinking and problem solving.

Did you feel prepared to enter the workforce after your primary degree and since have you obtained any fur-ther qualifications after your B.Sc Pharm/M. Pharm degree?I felt prepared and confident to enter the pharmaceu-tical industry after the B.Sc Pharm. Whilst I may not have had experience of regulatory affairs prior to my first position, many of the skills acquired through my undergraduate experience became applicable and rel-evant.

Since then, I have completed a MSc (Pharmaceutical Medicine) from TCD and a Diploma in Intellectual Property and Technology Rights Law from the Law Society of Ireland.

What experience do you feel has been the most rele-vant and helped you along your career?I held a very broad role which included medical in-formation, regulatory affairs, pharmacovigilance and complaint handling. I gained a lot of knowledge in this role as it allowed interaction with both regulatory au-thorities, health care professionals, patients, wholesal-ers and manufacturing sites. This experience helped me to decide that I was most suited to regulatory af-fairs, and my most recent roles have specialised in reg-ulatory.

What do you feel has been most instrumental in you being where you are now in your career?I have been adaptable through my career, and have changed role and responsibilities as demanded by business need. In 2012, the Irish and UK affiliates merged which resulted in a change to my position and frequent travel. However, through adapting to the new role, I found many new exciting opportunities and continue to learn about the UK market. Change is constant in any organisation and it is important to be flexible and adaptable.

7

If you could give advice to a student who was interest-ed in progressing in a similar direction, what advice would you give?Keep an open mind when looking for a position. In general, pharmaceutical companies provide excellent training opportunities. It is often easy to move in to a different role within a company. My experience is that a job is often what you make it and is not constrained by a job description or job title.

If you were to pick just one aspect of your job, what would entice students in to a career in your specialist field of work?It is a field which is always changing and which re-quires constant learning, so I think it would be at-tractive to anyone who is constantly looking for new things to learn and develop.

How do you see the future of Regulatory careers to develop?The medical device industry in Ireland has grown rap-idly over the past few years and no doubt this will be an area which will see employment growth.

8 Issue 3, Volume 1 | Feb 2015

Niall O’SheaGlaxoSmithKline

What tasks would a typical week involve? And how does this differ to a regulatory career within the Health Product’s Regulatory Authority (HPRA)?In the morning, I’ll spend the first hour or so check-ing my emails and planning for the day. I also try to use the quiet time to review advertising copy. Items of promotional material and artwork will cross my desk for review and approval throughout the day. At 9:00 the meetings start and the day is peppered with them.

New product applications and maintenance of exist-ing products takes up significant time for medicines, so we need to dedicate significant time liaising with plants, our own central offices and the HPRA to en-sure that we can get safe, high quality products to mar-ket as quickly as possible. Regulation of nutritionals, medical devices, cosmetics and our other products is also increasing at considerable pace, so we also spend time ensuring we are aware of changes in regulations and how this will affect us and how we can use this to our advantage.

I also spend time maintaining and ensuring our Qual-ity Management System is fit for purpose – mainly through reviewing and ensuring our Standard Op-erating Procedures (SOPs) are trained out. When we are doing our job correctly it ensures the quality of our products and means that external agencies do not need to intervene.

I also frequently have external meetings with our stakeholders. This can be the HPRA, the Food Safe-ty Authority, our industry associations or some of the key opinion leaders in one of the categories in which we operate. It is important to get out there and speak with our stakeholders and those who in turn interact with them to ensure that our mission is clearly un-derstood. I am also in frequent contact and regularly visit the other GSK sites in Ireland. While the sites all have different functions, we all operate under the GSK name and are all regulated by the same authority, the HPRA.

The HPRA would also deal with all of the above, but from a different perspective. While a career within the HPRA would be different in some ways, we are ulti-mately all working towards the same goal – to ensure that medicines of high quality are placed on the mar-ket quickly to the benefit of patients.

What kind of person do you think this career would suit?Attention to detail and clarity in communication are particularly important for a Regulatory Affairs posi-tion. A career in Regulatory Affairs would suit some-one who can exhibit these skills.

Issue 3, Volume 1 | Feb 2015 9

What do you feel are the most challenging and most enjoyable aspects of your job?There is a constant balance between the various parts of my role. I work in Regulatory, Quality and External Affairs among others and there are always things hap-pening in each area. It is important that each area gets the right amount of time devoted to it.

As a career, what I enjoy most about my current role is the fact that no two days are the same. I also like that it is very much a team operation and that the peo-ple who operate within that team make it much more than the sum of its parts.

Did you feel prepared to enter the workforce after your primary degree and since have you obtained any further qualifications after your B.Sc Pharm/M. Pharm degree?The pharmacy degree is an excellent preparation for entry into the pharmaceutical industry, but the degree of itself cannot be taken as a passport for entry. I be-lieve strongly in continuing development and was a member of the PSI’s Professional Development and Learning Committee for a period of time. Since quali-fying as a pharmacist I have gone back to college twice, to get a post graduate diploma in Health Economics and a Masters degree in Pharmaceutical Medicine.

What experience do you feel has been the most rele-vant and helped you along your career?I have found almost all of the experiences I have had within the industry to be positive. I worked abroad, in Italy, for a short period and found this to be very useful in allowing me to experience a different culture and way of working, which was very useful on my re-turn to Ireland.

What do you feel has been most instrumental in you being where you are now in your career?The most important thing in my career development, in my opinion, is a willingness to be flexible, within set parameters, in pursuit of long term goals. Any projects I have undertaken have all contributed to my learning and have enabled me to progress profession-ally. Clearly it is also important to have a good work ethic.

If you could give advice to a student who was interest-ed in progressing in a similar direction, what advice would you give?I would give consideration to what it is about the in-dustry that appeals to you and apply for available po-sitions. It is important to find something that you like and are good at, which will allow you to work your way up within a company more quickly.

There are opportunities in all fields – manufacturing, quality, health economics, regulatory, clinical trials, compliance. It is important to note that opportunities will not always present themselves in the area, at the time or even the part of the country that may ideally appeal to you. At the outset, it is useful to get some experience with a company and you may find that you like a particular area and you could get an opportu-nity to work in other areas of that company or get ex-perience which would then be useful in applying for other positions.

If you were to pick just one aspect of your job, what would entice students in to a career in your specialist field of work?My job is very varied and as I said no two days are the same which makes it very interesting and even till now there is always something new to be learnt. Working in Regulatory Affairs is also a great opportunity to meet people from different backgrounds as you could find yourself in close contact with our counterparts in the Middle East, Africa or other parts of the world.

How do you see the future of Regulatory careers to develop?The experience in other sectors (e.g. finance) has shown the importance of sound and balanced regu-lation. This is of particular importance in pharma-ceuticals and the experience so far in Ireland specif-ically has been positive, with the strong Regulatory environment here actually being a factor in attracting investment. As there will always be a requirement for Regulation in a sector such as this and as the sector is well established in Ireland, it is likely that Regulatory Affairs will continue to develop here, within the EU and Globally.

Michael LennonHealth Products Regulatory Authority

What tasks would a typical week involve? And how does this differ to regulatory career within a pharma-ceutical company?I work as a Quality Assessor within the Health Products Regulatory Authority so my primary role is assessment of the pharmaceutical quality of products from the dossiers submitted by drug companies in their applications for the authorisation to market a medicinal product. I currently work assessing, with my European colleagues, drug applications that are intended to be marketed throughout the EU. This involves reviewing the quality data submitted cover-ing drug substances, the finished product and how it will be presented to patients and pharmacists. I also supervise the work of a team of three other assessors in this area by coordinating and assisting them in progressing their assessments. We meet, both on a one-to one and a team basis, each week to discuss and resolve technical issues and quality issues that may impact how the patient and healthcare profes-sionals interface with the product. The role of an as-sessor also involves working with external stakehold-ers subsequent to authorising a product by liaising with patients/prescribers/pharmaceutical companies on quality related issues.

In addition to my assessment work I am also the HPRA delegate on the European Medicines Agen-cy (EMA) Quality Working Party (QWP). This is a group of quality experts from all the European medicines agencies who meet quarterly at the EMA in London to progress policies for quality assessment within the EU and to resolve complex quality issues that arise during assessment procedures. Substantial preparatory work occurs at the national agencies in advance of these meetings so I spend significant time every week bringing European positions for national consideration and formulating the Irish position for representation at the EMA.

There are certainly parallels between regulatory ca-reers within the HPRA and a pharmaceutical com-pany but we are on different sides of the same fence! Some of the goals and objectives of industry roles would differ from HPRA but I do think patient safety is a shared goal whichever side of the fence you are on. Industry roles are usually multi-market focused (due to the global nature of the pharmaceutical industry) whereas HPRA assessment is focused on

national and European work.

What kind of person do you think this career would suit?The position has both a regulatory affairs and a technical dimension and so draws on different skill sets depending on what you are focusing on at a par-ticular time. But there are common skills required for all the work and these include a problem solving ability, being able to consider the details in parallel to ‘big picture’ issues and being able to stay critical and interpretative in the face of substantial data. Pharma-cists, as scientists are generally very well suited to this type of work. It is less of a patient facing role than hospital or community pharmacy but still involves substantial communication with other internal and external stakeholders on a daily basis, so it’s very important to have good interactive skills.

What do you feel are the most challenging and most enjoyable aspects of your job?All of the assessment work that I currently do is con-ducted to strict timelines (mandated by EU legisla-tion) so it can be very challenging at times constantly working to tight deadlines (while balancing other work such as meetings, QWP work, etc). I have to say I really enjoy the diversity of the role as it’s much more than just assessment work. As the HPRA is a relatively small agency (compared to other European regulators) each quality assessor gains exposure to many types of dossier submissions and complexities from generic product applications to assessment of products to be used in clinical trials. The pharmaceu-tical industry is still quite innovative so there are al-ways new proposals coming through that need to be assessed with the view to improving health outcomes for patients and this can be very enjoyable.

Did you feel prepared to enter the workforce after your primary degree and since have you obtained any further qualifications after your B.Sc Pharm/M. Pharm degree? I did a B.Sc Pharm degree in Trinity and graduated in 2005. The degree is extremely relevant for a role that combines regulatory affairs and technical as-sessment. The breadth and depth of the pharmacy syllabus provides an almost unparalleled training for understanding and contributing to the quality of medical products. However, no single course can completely prepare you for a role after graduating, so on-the–job development is a continual and stim-ulating aspect of the position. There are pharmacists

10 Issue 3, Volume 1 | Feb 2015

working in many different sections of the HPRA. These pharmacists have primary, masters and doc-torate qualifications, and whether they use their extensive pharmacy education or specialist research experience they present very attractive skill sets to employers for regulatory and technical positions. However, there is no doubt that the jobs market is very different now compared to when I joined the agency, so it may mean that employers may look for more differentiating factors now, for instance a demonstration of additional skill sets or further education above the primary pharmacy degree for certain roles.I have done some on line project management cours-es since I obtained my degree but haven’t undertaken any master’s program to date.

What experience do you feel has been the most rele-vant and helped you along your career?I guess in career terms I’m still relatively young and I feel I’m still carving out a career path for myself. I am almost seven years with the HPRA and have been fortunate enough to have worked on many projects with clear objectives in relation to public health benefits, in addition to my quality assessment work, which I feel has been of great benefit in terms of my own progression within the organisation. Working with those clear objectives in terms of public health enables a focus that benefits your own development. But I also firmly believe that any work experience is good work experience as long as it is used prop-erly. I travelled a lot in my undergraduate years and after the pre-registration year and I think this type of experience has helped my personal development immensely.

What do you feel has been most instrumental in you being where you are now in your career?Without a doubt my undergraduate pharmacy degree at Trinity steered me in the direction to where I cur-rently am. Then, working in community pharmacy before I joined the agency the patient facing expe-rience has given me a better understanding of, and empathy with, the issues encountered on a day to day basis by patients and healthcare professionals. This understanding very nicely dovetails with assessing the quality and usage of medicines.

If you could give advice to a student who was in-terested in progressing in a similar direction, what advice would you give?If you’re genuinely interested in regulatory or techni-cal roles use the tools available to you at undergradu-

ate level. Attend the CV clinics offered by PIER; sign up for summer placement positions (or seek some out yourself abroad if you want to travel); talk to your lecturers about their contacts/peers who are in industry. It does take some determination to get into industry roles, no one is going to hand one to you but for those with a genuine interest and willing to look at various positions there are plenty of options out there. And with the education from the pharmacy course (and some drive!) pharmacists are well placed to secure interesting positions.

If you were to pick just one aspect of your job, what would entice students in to a career in your specialist field of work?Diversity- the HPRA is a growing organisation, the roles have expanded and developed significantly in the past seven years. There are plenty of opportu-nities for pharmacists within the organisation, the work is interesting and you never know what next big project is around the corner in terms of medicines regulation.

How do you see the future of Regulatory careers to develop?I would really like to see a lot more pharmacists working within the industry in general not just in regulatory roles. The pharmacy degree is one of the most relevant undergraduate courses available in Ire-land for the pharmaceutical Industry. I am currently serving on the committee of PIER Ireland (Pharma-cist in Industry, Education and Regulatory), a repre-sentative group established to represent the interests of all pharmacists in roles other than the traditional patient facing roles. One of the main objectives of this group is to represent and develop pharmacist’s professional status within the industry. The promo-tion of the activities of this group within the industry alone should be beneficial in establishing the benefits and consequently more roles for pharmacists within the industry over time.

Irish Pharmaceutical Students’ Association

Issue 3, Volume 1 | Feb 2015 11

IPSA Irish Pharmaceutical Students’ AssociationRoom 33, Goldsmith Hall, Trinity College,Dublin 2

Email: info@ipsa-online.com

IRELAND’S NATIONAL PHARMACY STUDENT SOCIETY© 2015