- Bachelor's or Master's in Pharmacy, Life Sciences, or related fields with knowledge of Pharmacovigilance and safety databases
- Review and process Individual Case Safety Reports, code adverse events using MedDRA, draft case narratives, ensure regulatory compliance, and assist in safety report preparation
Role & responsibilities
- Review, triage, and process incoming Individual Case Safety Reports (ICSRs) related to adverse drug events.
- Perform accurate data entry of patient details, medical history, and adverse events into safety databases (like Argus or ArisG).
- Use standard medical dictionaries (MedDRA) to properly code adverse events and medications.
- Draft clear, chronological narratives summarizing the details of each safety case.
- Ensure all case processing meets strict regulatory timelines and compliance standards.
- Follow up with healthcare professionals or reporting individuals to gather missing case information.
- Assist the clinical team in preparing aggregate safety reports for regulatory submissions.
Preferred candidate profile
- Education: Bachelors or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Biotechnology, Nursing, or related healthcare fields.
- Experience: 0 to 1 year (Freshers welcome); basic knowledge or certification in Pharmacovigilance/Clinical Research is a strong advantage.
- Technical Skills: Familiarity with medical terminology, drug classes, and basic understanding of safety databases.
- Soft Skills: Solid attention to detail, excellent written communication (specifically for drafting narratives), and the ability to strictly manage time and deadlines.