Getting Started in Pharmacovigilance – Part 1

Jun 16, 2016
Bart Cobert

医薬品安全監視、医薬品安全性および規制関連業務に関する執筆者・専門家

As I have been in the Drug Safety and Pharmacovigilance business for over 30 years and having written books and blogs and articles on the subject, I’m frequently asked how one can get started in the business. As each person is different, the answers will often vary from person to person. What I will try to do in this post and the next one is summarize the points that are common to all and try to give broad suggestions that will cover most readers who are interested in a PV career.

This post is in two parts.  Here is part 1.

 

Do you really want to do PV?

The first thing I would suggest is to really think about whether you are interested in PV. Of all the fields in the pharmaceutical world, this is not necessarily one of the “happier” ones! By this I mean the PV department collects side effect (adverse event) data on the companies’ products, analyzes the information (signals) and recommends changes and warnings to labeling or to clinical trial protocols.

To put it another way, we do not generally deliver good news to management, the FDA and the public. You will be challenged every step of the way when delivering problematic news to management (“We’re not adding that side effect to the label till you PROVE to me it is really due to the drug.”).  The head of drug safety is often called “Dr. No”.  It is not a career track to senior management as a rule. So think carefully about whether you want this as a career, especially if you aspire to a senior position. You many want to try another area in the pharma world or you may consider this just a way to get your foot in the door and then move to a different non-PV position.

On the other hand, PV is ultimately a “Sherlock Holmes” detective job in which you get limited information and must make a rapid judgment and take action in many cases to prevent harm. It can be very intellectual, challenging and unexpected. In many of the jobs, each day is different and the next email may be a crisis or disaster. Some people love this and others flee!

 

Figure out what sort of job you want and your qualifications.

Consider several questions:

 

What types of jobs are there in PV and which ones should I consider?

PV is now more complicated, diversified and complex that it was years ago. There are multiple areas now to consider in PV.

Some are clearly specialty jobs:  Statisticians, epidemiologists, IT and computer experts represent clear subspecialties where knowledge of pharmacology and medicine/biology may not be as obligatory as it is in other jobs within PV.

The next group are clinical jobs requiring various levels of medical/clinical/pharmacology knowledge: reading medical records, writing narratives and entering data into the MedWatch/CIOMS form or computer safety databases. These jobs can exist in the clinical research department, the drug safety department, sometimes in regulatory affairs, sometimes in medical writing and elsewhere. This varies from company to company. Here one must have the skill set to read incoming hospital and patient records, case report forms (either electronic or paper), FDA reports, medical literature, pharmacy and technical labeling data etc.  These jobs tend to go to nurses and physicians though many pharmacists, dentists and veterinarians have now trouble moving into these roles. Many docs and nurses feel most comfortable doing these types of jobs rather than more operational jobs. Many also like risk management and analysis jobs which involve review of clinical case series, signals, literature reports etc.

Then there are operational jobs. In large companies, upwards of 100,000 or more adverse events can be received each year with many different types of reports (expedited reports, DSURs, Annual Safety Reports, PSURs, PADERs, PBRERs, REMS, RMPs etc.) required for over a hundred health agencies in addition to FDA.  For large pharma companies with hundreds of products this produces enormous amounts of data, reports, mailings, notifications, label changes, protocol reviews etc. The management of millions or billions of pieces of data, letters/emails and thousands of reports requires complex logistics. There are now many in the business who are expert at setting up complex PV systems to ensure that the right data goes to the right places at the right time. They are, in effect, PV Chief Operating Officers (VP PV Operations). The skill sets here are not so much medical and pharmaceutical knowledge but rather IT, systems, quality, compliance and other non-medical managerial skills. People can enter these jobs from other parts of pharma or even other industries and do very well.

There are jobs that touch PV as well as other areas.  These include regulatory affairs, legal, clinical trial safety specialists, compliance and auditing specialists, quality personnel and others.  This might be for you depending on your skills, temperament and interests.

 

What academic degree(s) do I have and do I fit with PV?

There are a large and diverse number of degrees that work in PV. They include MD, DO, RPh, PharmD, RN, LPN, DDS/DMD, PhD, DVM as well as folks with MS, BA/BS and Associate degrees.  More recently people with IT, computer, epidemiology and statistical degrees are getting jobs in PV.

Some jobs are clearly tailored to certain degrees.  Broadly speaking the senior jobs (particularly those with senior medical responsibility) are most often MDs.  Jobs that require clinical judgment (for both medical and legal/regulatory reasons) will, of course, generally require people with clinical degrees (MD, RN, LPN, DO and sometimes pharmacists with strong hospital and clinical experience rather than retail pharmacy).  Other jobs may be non-clinical and do not require experience in the hospital or doctor’s office.

Also consider where your degree is from (the US/Canada, Europe elsewhere) and how it will be viewed by a hiring manager.  Did you do additional training (an internship/residency for example).  If an MD/DO, are you US/Canadian board certified?

How good is your English if not a native speaker?  Can you write cogent narratives? Do you want to work more with people or with data?  Are you analytic? Can you tolerate unexpected “crises”?

 

Experience and job history

Unfortunately, like many jobs dating back centuries, the old rule still often applies: “You can’t get a job without experience and you can’t get experience without a job”. In other words, breaking into the game may be the hardest part.  Companies do not like to train new employees now the way they did in the 1990s and 2000s.  Training budgets have been cut and the more desirable hires are those who have experience in the job they seek. They will only need to learn the new company’s idiosyncrasies rather than the whole job from scratch.

So you have to be realistic about what job you are qualified for based on your degree and your experience.  There are rookie, starting jobs out there but they are often highly competitive and hard to get.

In general, any work you have done, even indirectly, on clinical trials, drug use, drug safety, etc. is important and should be highlighted in your CV.

Are you willing and able to work in a corporate or government (e.g. FDA) environment?  Have you always been a doc in private practice, a pharmacist in a store etc. where you’ve had autonomy and perhaps you did not work in a real hierarchy with a boss directly over you.  If so, are you going to be happy in a corporate, hierarchical environment?

Are there any “bad marks” in your CV or history that will be a red flag in the job hiring process.  Remember that everyone now gets googled and has their Facebook, LinkedIn and other social medial profiles examined.  Any bad surprises in there?  Google yourself, particularly if you have an uncommon name, to see what’s out there.

So be realistic about what job you are qualified for and can realistically bid for.  See the sections below on how to go about doing this.

 

You see a fit, your qualifications seem right.  What next?

The next steps involve getting your “employment package” ready and researching what is out there for you.

The Employment Package

CV & Resumé: At the very least you need a well written, concise, totally accurate CV (curriculum vitae) and resumé. There are many formats and ways to do this.  You can search online for formats and advice on how to set them up. The CV is usually longer and more detailed. The resumé is a shorter summary. If you are first starting out your CV may be short enough whereby you don’t really need a resumé.

A few pointers. No mistakes, spelling errors, sloppiness, lies, exaggerations etc. Many things can be checked by the potential employer or Human Resources online. Many CVs are often received for each job and the sloppy ones and those with errors will be tossed away immediately on the presumption that your work on the job will be equally sloppy or erroneous.

Get the key points you want to make on the first page, preferably on the top of the first page.

Figure out what jobs you might want to apply for and, if appropriate, prepare several versions of your CV to cover various jobs. If you’re looking for a clinical research job you may want to change the order or give more detail in the sections that touch on clinical research. If you’re also applying for an operational or IT job then the CV may be reordered or changed stress these areas. Keep track of which CV you send to which potential employer!

Most CVs and resumés will highlight the job or type of position you are searching for in a sentence or two at the top. This “headline” is a quick way of telling the reader who you are and what you’re looking for.

Work Samples or Attachments: In some cases it may be appropriate to attach an article you wrote or a case narrative you prepared (be sure there are no privacy or copyright issues preventing your using it).  This is not common but may be appropriate in some situations.

References: At some point, usually later in the hiring process, you will be asked for references.  This is a complex area too.  You obviously want several folks who will speak well for you.  Hiring managers and HR folks fully understand how this works and expect most references to be positive to very positive.  The best references, in my experience, come from people who speak very positively but can also credibly answer questions about the candidate’s weak points, areas that need improvement etc. That is, references who say that the candidate “walks on water” can be too glowing and less believable. Hiring managers and HR know how to dig out information when talking to references.  So choose your references carefully and tell them they may get a call or email.

“Elevator Speech”: This is a cute term describing a few sentences in which you cogently summarize who you are and what you want. The idea comes from the concept that you enter an elevator in a tall building and are standing next to Bill Gates (or a possible employer) and you have 30 seconds at most till he or she gets off to introduce yourself, say who you are and what job you’d like. You need to be able to do this flawlessly and get all your points across. That is, you have to “make the sale” in 30 seconds or so.

There are consultants and coaches out there who will help you prepare all of this if needed. Be careful though; many are not good at what they do. Your best bet is to speak with someone who is in the business, hires people and is willing to help you on a mentor basis. If you do hire a coach, check his/her references and track record if you can.

LinkedIn: If you are not on LinkedIn already, you should be.  Set up a detailed profile but be very very careful about what you say.  Be careful of personal information, your private email address and other details.  Be careful also if you currently have a job and do not want your employer to know you are looking for a new one!  If you are able to indicate you’re looking for a job, then get your education, work experience (if any) and other relevant information from your CV on your profile.  The headhunters will find you. As always, be careful as there are lots of unscrupulous players out there who do not have your interests at heart.

 

Permanent vs. Temporary Jobs

There is a clear trend now in the US and Europe away from hiring full-time employees. Rather, companies feel they have more flexibility by hiring “interims”, “consultants”, “contractors” on short-term bases anywhere from 3 months to two years. You will not get most or any benefits but rather a straight hourly (or daily) salary and nothing more. This may or may not lead to a full-time job either at that company or elsewhere. On the other hand, one can get valuable experience, learn the job, strengthen your CV and land a full-time job after the short-term gig ends.  For many, this is a good way to start in PV.

More to come in Part 2 where we will get into the specific things to be done.

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