“Pharmacovigilance has been defined by the World Health Organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem”.
To put it in simple words, PV department collects side effect data on the companies’ products, analyzes the information and recommends changes and warnings to labeling or to clinical trial protocols.
How does it feel to work in PV:
- Working in PV is can be very intellectual, challenging and unexpected because we are not delivering any good news to authorities and companies.
- The data which we are sharing with regulatory authorities can lead to drug withdrawal from market, so it will be very challenging and we must make a rapid judgment and take action in many cases to prevent harm.
- We need to work on toes due to timelines which we cannot afford to miss it.
- Unlike in other jobs each day is different here and we never know whats in our way next morning.
Type of Jobs in PV:
- Core clinical team requiring medical, clinical, pharmacological knowledge: This team handles ICSR processing and aggregate reporting.
ICSR (Individual case safety reporting) processing includes multiple steps depending on experience we have in domain. Below are steps:
1. Case collection and triage team
2. Data entry
3. Case processing
4. Quality review
5. Medical review
Major activities include: reading medical records/patient reports /adverse event reports, writing narratives and entering data into the computer safety databases, performing seriousness, labelling and causality assessments.
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.
Aggregate reporting: This team handles DSURs, Annual Safety Reports, PSURs, PADERs, PBRERs, REMS, RMPs etc.
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 assurance team.
Required qualifications to work in PV:
Physicians, Pharmacists (RPh, PharmD, Bpharma, Mpharma), Nurses (RN, LPN), Dentists (DDS/DMD), science graduates with 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.
We need to consider below points before apply for any PV role:
- How good is your English?
- Can you write cogent narratives?
- Do you want to work more with people or with data?
- Are you analytic?
- Can you tolerate unexpected “crises”?
- Can you handle work pressure and over work?
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