J B Chemicals and Pharmaceuticals Ltd. – Opening for Pharmacovigilance
Roles and Responsibilities
- Preparation of essential PV related documents such as PSUR (Periodic Safety Update Report), PADER (Periodic Adverse Drug Experience Report), RMP (Risk Management Programme) etc..
- Handling ADRs (Adverse Drug Reactions) & generation of ICSR (Individual Case Study Report)
- Replying to medical & product related complaints
- Literature search & generation of report in E2B XML format
- Preparation of SmPCs, PIs & PILs.
- Preparation of CTD dossier
- Training – Pharmacovigilance
Desired Candidate Profile
Qualification: M. Pharm / BHMS / BAMS
No of year’s exp : Min 3-4 yrs experience
Nature of Experience: Pharma Industry
Essential Skills: Pharmacovigilance
Desired Skills: Clinical Trial / Medico-Marketing