Pharmacovigilance is a pharmacological science concerned with the detection, assessment, understanding and prevention of adverse reactions, in particular long-term and short-term side effects of medicinal products. In general, Pharmacovigilance is a science of collecting, monitoring, researching, evaluating and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbal products and traditional medicines with a view to: identifying new information on risks associated with medicines that prevent harm to patients. Pharmacovigilance is especially concerned with adverse drug reactions or ADRs that are officially described as: ‘ Response to a drug that is noxious and unintended and that occurs at doses normally used for prophylaxis, diagnosis or treatment of illness, or for physiological function modification.
Drug Safety Associate Responsibilities / Case Processing Expert/ Pharmacovigilance Associate
Drug Safety Associate oversees activities related to the collection, sorting, monitoring, review and regulatory reporting of adverse event(s) and severe adverse event(s) for marketed drugs and experimental products.
The DSA ensures the prompt delivery of regulatory agencies ‘ reports in compliance with relevant legislation and that all FDA and other drug regulatory agencies ‘ inquiries are replied to in a timely manner. DSA must respond to inquiries from health care professionals, customers and company staff on safety issues related to marketed products; prepare regular, thorough written reports of all assigned AEs; identify potential sources of product litigation; collect AE data from various clinical trial cases and random sources; handle case-related information, including analysis of product litigation;
Who hires Pharmacovigilance Professionals?
People trained in Pharmacovigilance can find excellent work opportunities in following organizations:
- Pharma-Companies ( Novartis, Dr. Reddys, Ranbaxy etc)
- Contract Research Organizations (CROs)
- Biotech companies.
- IT Companies like Accenture, TCS, Cognizant, Wipro, Mahindra Satyam etc
- Regulatory Authorities such as DCG(I), FDA & CDSCO