Over view of Pharmacovigilance
Pharmacovigilance (PV or PhV) is the science related to the detection, evaluation and prevention of adverse effects of drugs, biologics or medical devices. It includes the study of both short-term as well as long-term adverse effects experienced with the use of a therapeutic in a post-marketing or clinical trial setting. Pharmacovigilance is evolving as a strategic discipline for the drug development and pharmaceutical marketing companies and includes the tools, systems and methodologies used in collecting, monitoring and evaluating adverse event data from patients using drugs, biologics, and medical devices in full compliance to the regulatory framework or guidelines.
Pharmacovigilance systems are designed to
- Determining new information about risks related with drugs
- Confirm with secondary and primary research methods the risks (signals) identified
- Minimizing the risk and providing more safe medication to the patients (Risk Identification and mitigation)
- Be advisory for new drug discovery and development
According to a market research report published recently by ‘Transparency Market Research’ titled “Pharmacovigilance Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 2020”, the worldwide market for pharmacovigilance was almost 2,426.6 USD in the year 2013 and will cross USD 6,104.1 million in 2020 with an estimated CAGR of 14.2%.
A career in Pharmacovigilance is interesting with a well described career path. The career development is quick which gradually leads to managerial and director positions with excellent pay packages. Pharmacovigilance is a good career choice for life science graduates including pharmacy, pharmacology, medicine and alternative medicine. It is a highly advanced scientific discipline that is mainly involved with reporting and assessing of drug adverse effects. Pharmacovigilance professional’s responsibility is to make sure that drugs available in the market are safe and those drugs which are identified unsafe are removed from the market or appropriately labelled if the risk-benefit ratio justifies their continuous use. Once a drug adverse event is reported, the Pharmacovigilance specialists enter the event in appropriate databases, follow-up with the case to collect more data and forward these data to regulatory agencies and other appropriate authorities if needed, after due medical review.
Hierarchy in Pharmacovigilance sector
Drug Safety Associate: The Entry level job in Pharmacovigilence is Drug Safety Associate (DSA). Drug Safety Associates are mainly engaged in case development, examining for Minimum safety information ( MSI), reconciliation and follow up procedure, data entry of all details available in the document and medical coding.
Drug Safety Scientist :Once a professional attains an experience of 2-3 years in DSA position and builds the necessary skill such as Medical coding, scientific writing and narrative writing , a great understanding of medical terms and primary understanding of regulatory affairs, ICH-GCP and compliance etc., he/she can go on to become a Drug Safety Scientist (DSS).
Aggregate Report Scientist: Professionals who have obtained excellent narrative writing skills can work on much critical tasks like individual case narratives, PSUR (Periodic Safety Update Report) and PADER (Periodic Adverse Drug Experience Reports) development and are referred to as Aggregate report scientists.
Team lead: With overall of 5-6 years experience in Pharmacovigilance an individual can become a Team lead or Team manager.
Director: Finally, professionals move on the management hierarchy and with further experience and business skills move to directorial roles within 10-15 years.
Who hires Pharmacovigilance professionals?
Clinical research organisations
BPOS / KPOs
Pay scale for entry level jobs in Pharmacovigilence
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What are the courses to be taken to become a Pharmacovigilance Professional?
Advanced PG Diploma in Pharmacovigilence and Regulatory Affaires
Professional Diploma in Pharmacovigilance and Pharmacoepidemiology