Getting Started in Pharmacovigilance – Part 2

Jul 12, 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

This is Part 2 of Getting Started in Pharmacovigilance.  In Part 1 we talked about concepts and starting the preparation for job hunting.  Here are the next steps:

Familiarize Yourself with PV and Drug Safety

If you are new to the game and have little or no experience, you need to be frank and up front about this. A hiring manager will be able to trip you up immediately if you claim to know more than you really do.  A simple, but jargon filled question can pick this up right away. (“So, do you think we should submit an old-format PSUR or PBRER or PADER?” or “Can you code in MedDRA and how do you handle verbatims?).

If you are a rookie, at the very least you should read some websites, articles, books, etc. to be able to hold a conversation and indicate why you want to head into this field.

Take a look at the PV sections in various websites including:

  • FDA: Drug Safety and other pages within CDER
  • EMA: Pharmacovigilance and other pages
  • MHRA (UK): Good pharmacovigilance practice for medicines and other pages. This is an excellent website with lots of information touching on the UK and EU but the general concepts are applicable everywhere.
  • Pharma Companies: Many big companies have general information about drug safety.
  • Blogs and the Internet: Lots of information out there. I write a blog (you’re reading it!) at C3iHC.com.
  • LinkedIn: As noted in Part 1, LinkedIn can be a tool that will let the world know you’re looking for a job. However, it is also a fine way to learn about PV and Drug Safety. Perhaps the best way to start is to look at the dozens of groups on LinkedIn that deal with drug safety, pharmacovigilance, clinical trials, FDA, EMA and other regulatory agencies etc.  Lots to wade through but lots of information.  Join some and participate in the discussions if you wish.
  • Books: There are several published. Look on Amazon and other sites.  I have written two books that may be of use:
    • Cobert’s Manual of Pharmacovigilance and Drug Safety 2nd  or Amazon.  I wrote this in 2012 and there have been several changes since then, particularly in the EU, that are not covered.  Most is still applicable.  The US practices and regulations have not changed as much. And remain largely up to date. This is an easily readable, basic text on PV.  It covers operational aspects of DS and PV but not the medical aspects.
    • Drug Safety Data. Michael Klepper and I wrote this book and it covers the medical and clinical information on DS and PV. Both are also available on Amazon.Another comprehensive text is:
    • Mann’s Pharmacovigilance 3rd – Excellent and encyclopedic.

 

Look for a Job!

After you’ve done all or some of the above, it’s actually time to start hunting for a job.What sort of jobs are there?

Here’s a list that covers most jobs in PV.  Titles and functions vary from company to company, employer to employer.  All levels exist: manager, associate, specialist, senior specialist, VP, director, executive director etc.

  • Drug safety/PV scientist/specialist/associate
  • Drug safety/PV manager
  • Medical/Safety/PV reviewer
  • PV Quality/compliance specialist/associate
  • Clinical Quality specialist
  • Medical Safety scientist/specialist/reviewer
  • Local safety officer
  • Clinical trial/project safety associate/reviewer/specialist
  • Data management/governance/operations manager/associate etc.
  • MedDRA coder/specialist/associate
  • PV safety and analytics reporting analyst/specialist/associate
  • PV Auditor/ PV Inspection readiness officer
  • Safety/PV physician
  • Medical writer/safety
  • Good PV Practices specialist/manager/director
  • GCP specialist (may or may not cover safety)
  • PV vendor and case processing specialist
  • Clinical trial case processing safety specialist
  • Post-marketing case processing safety specialist
  • Epidemiology/statistics safety associate/manager
  • Risk management/assessment/minimization manager, director etc.
  • Signal management reviewer/specialist
  • Periodic reporting specialist/manager
  • Regulatory affairs safety specialist/manager etc.

There are other permutations and titles that will cover safety and PV in one way or another.  So cast your net widely.

Personal Contacts:

By far, the best way to get a job is via personal contacts either directly or through a recommendation from someone who knows you and will help you get in contact with the right people.  To do this, go through your contact list and look for people you know in the industry, in pharmacy or medicine or related fields.  Look for those folks who might be able to put you in touch with people who might be able to hire you. If not, they might know someone else who can to hire you or at least advise you or refer you to someone else.  This can be a tedious and painful process but can lead to success.  If you don’t know anyone in the industry doing PV but do know someone in, say, marketing or sales, don’t hesitate to contact them and see if they can put you in touch with the PV folks.

At the very least you want a specific name (and hopefully contact information) of a person in PV you can write to or call.  If they’re local, offer to take them to lunch or meet for coffee. People can be very busy so consider an early breakfast at a location convenient to them before starting work. Starbucks or Panera are good for this and they have free wifi!

Corporate Websites:

Look for the “Careers” or “Jobs” section on pharma company websites and LinkedIn, DIA, etc.  Look at large and small pharmas as well as Clinical Research Organizations (CROs). Google these and search widely. Although jobs are often posted here, this is not usually a fruitful avenue to find a job. The sites often get hundreds (or more) CVs for each posting and your CV will just get put on the pile and often not even looked at. Nonetheless, it is worth doing. If possible, should you find a posting on the website AND if you know someone at the company, contact that person to ask for the name and email address of HR (or perhaps the hiring manager) and consider sending your CV directly to that person or a named person in HR. Not everybody in the company appreciates this but it is done.

There are companies that consult to the pharmaceutical industry who hire PV personnel. Usually they want experienced subject matter experts.

Health Agencies:

In the US, consider looking at the FDA/federal website for job postings. FDA has offices around the country and there might be opportunities there. Some state and local health bureaus may also have such positions. Similarly, outside the US, nationals of that country may want to look at their health or drug agencies for positions.

Headhunters:

The barriers to entry for becoming a headhunter are low (you seem to need only a phone, a computer and a LinkedIn profile). There are many out there and they will approach you if you make it known on LinkedIn that you are looking for a job. Some will claim to have “exclusives” and want you to sign up with them only. Beware. This may or may not be true and may or may not help you. Most headhunters will not do much “handholding” or coaching. Headhunters may be more useful for more senior positions (e.g. VP or Executive Director) than entry level ones.

Coaches:

There are many folks out there who, for a fee, will guide you through the process and, hopefully, help you find a job.  Again, be leery. The barriers to entry are low and many will not be specialists in PV or even in pharmaceuticals but will do more handholding and work with CV preparation, interview preparation etc. This may be fine for true rookies who don’t know how to go about finding a job or who have not been in the job market or had in interview for twenty years. Try to find an experienced former pharma person now doing coaching.

 

Summary

So, to summarize, finding a PV job is certainly possible. It may take persistence, a lot of work on your part and can certainly take months or more. Be flexible. Your first job will almost certainly not be your last job.  It will be a stepping-stone till you find the right job, at the right company.  Good luck!

 


*** PS: I am not able to give individual advice, coaching or mentoring, so please do not ask.  Sorry.
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