Role & responsibilities
Case processing: Receive and process Individual Case Safety Reports (ICSRs) from sources such as patients, healthcare specialists, clinical trials, literature, and regulatory authorities.
Data entry: Accurately enter patient, drug, event, and medical-history information into the safety database.
Case assessment: Review cases for completeness, seriousness, expectedness, and possible relationship between the drug and adverse event.
Coding: Perform medical coding using standardized dictionaries such as MedDRA for adverse events and WHO Drug for medicinal products.
Preferred candidate profile For an entry-level Pharmacovigilance Associate, companies typically look for candidates with the following profile:
Educational qualification: B.Pharm, M.Pharm, Pharm.D, B.Sc./M.Sc. in Life Sciences, Biotechnology, Nursing, Medicine, or a related field.
Communication skills: Valuable written and verbal English, especially for preparing case narratives and follow-up queries.