“A career in Drug Safety /Pharmacovigilance is interesting with a nicely described career path”. The career growth is rapid in this field which gradually brings one to managerial positions with excellent salary packages.
Following is defined as what is Pharmacovigilance, what you expected to do as a pharmacovigilance professional, job description (JD), a list of potential employers, wage prospects and much more!
What is Pharmacovigilance?
“Abbreviated as PV or PhV, Pharmacovigilance is the science pertaining to the detection, evaluation, knowing and prevention of adverse effects (AE), especially short term and long term side effects of drugs”. Usually speaking, it is the science or technology of obtaining, monitoring, investigating, assessing and analyzing information and facts from healthcare service providers and affected individuals on the adverse side effects of medicinal drugs, biological and conventional medicines with a perspective to:
- Figuring out new information and facts about risks associated with drugs
- Protecting against harm to individual patients.
Why Should You Opt for Pharmacovigilance as Your Career?
Pharmacovigilance is an excellent employment option for pharmacy, medical and life science graduates. It is a scientific discipline that is generally involved with reporting and assessing side effects of medicine. It is mainly due to the function of Pharmacovigilance professionals that the medicines in the marketplace that we consume are generally safe and all those that are identified hazardous are taken off the market. Pharmacovigilance professionals constantly monitor the safety of the medicines in clinical trials as well as the medicines previously being marketed in the market. Just after a medicinal side effect is reported, the Pharmacovigilance professionals enter the event in appropriate databases, follow-up with the event to collect additional information and send these reports to regulatory authorities and other appropriate regulatory bodies.
How Has the Industry Worked Out so Far?
Establishing strict laws by regulatory bodies such as DCGI, US-FDA, EMEA etc. has directed to the adoption of a methodical Pharmacovigilance structure worldwide. This change had brought to the creation of huge number of job opportunities related to this sector.
In 2008, Pharmacovigilance market worldwide was US$ 186 million in 2008 and is projected to reach more than US$ 2254 by the year 2015.
Job Description of Pharmacovigilance Professional / Drug Safety Associate
- Pharmacovigilance / Drug Safety Professional are primarily engaged in case creation, reviewing for minimum safety information (MIS) which includes a patient, a reporter, a suspect medicine and an adverse event
- Reconciliation and follow up approach
- Data entry of all details readily available into safety database,
- Code adverse events in the safety database
- Review and assess all required source documents, and accumulate data in an adverse event report
- Execute labeling evaluation of adverse events
- Assessing adverse event to adverse events formerly reported and listed in the product label
Drug Safety /Pharmacovigilance Associate Salary
The initial remuneration for fresher’s is significantly based on their academic background, differing from year to year as well as from an organization to organization.
Drug Safety / Pharmacovigilance Associate Hierarchy
At a fresher level, employment for pharmacy or life science graduate is Drug Safety Associate. As mentioned above Drug Safety Associate is primarily engaged in case creation, reviewing for minimum safety information (MIS).
As soon as an individual obtains an experience of 2-3 years in that position and develops the expected skill sets (narrative and scientific writing, medical coding and superior understanding of medical terms, ICH-GCP, essential understanding of regulatory affairs and compliance etc) he/she can go on to grow to be a Drug Safety Scientist.
Individuals when having obtained a good narrative writing expertise can pursue it on a bigger shape, shifting from specific cases like writing for PSUR, PADER and as well as turning into a Aggregate report scientist.
With an overall of 6-8 years work experience in this position, a person can easily become a Team manager or Team Lead based on the organization.
Ultimately, individuals end up attaining the position of an Associate Director, Director or Vice-
President gradually depending upon years of experience.
Average Pay-scale of Pharmacovigilance Professionals
| USA | South Africa | Singapore | India | |
| Entry Level | $67,000 | R205,614 | S$42,833 | INR264,000 |
| With 4-5 Years Experience | $98,000 | R439,773 | S$80,427 | INR650,000 |
| More than 8-10 Years Experience | $136,000 | R845,833 | S$192,528 | INR14,000,00 |
Who Hires Pharmacovigilance Professionals
People trained in Pharmacovigilance can find excellent employment options in the following organizations:
- Pharmaceutical Companies.
- Contract Research Organizations (CROs)
- Biotech companies.
- Knowledge Process Outsourcing (KPOs) such as Accenture, Cognizant, Sciformix Corporation, iGATE etc.
- Regulatory Authorities such as DCG(I), FDA & CDSCO
What Training Program Can be Taken to Become a Pharmacovigilance Professional?
Some of the training programs that individuals can pursue to enter into this industry are:
- Professional Diploma in Pharmacovigilance & Pharmacoepidemiology
- PG Diploma in Clinical Research & Pharmacovigilance
- PG Diploma in Pharmacovigilance & Regulatory Affairs
- PG Diploma in Pharmacovigilance & Medical Writing
