Role & responsibilities
- Maintaining Standard Operating Procedures-SOP with Global PV system
- Preparation, review of PV SOPs and work instructions
- Complete ICSR (spontaneous, literature, regulatory and clinical trials) processing, QC and submission
- Preparation of PSUR, RMP and REMS
- Preparation of signal detection report and trend analysis
- Handling of regulatory authority queries and customer complaints
- Preparation of PI, MG, PIL, SmPC and CCDS
- Literature search, review and screening of ICSR and safety studies
- SDEA establishment and compliance check
- Product complaint handling, review and tracking
- Global AER database development, validation and revision
Preferred candidate profile
Candidate with 2 - 7 Years of relevant experience
Interested candidates are requested to share their CVs on
[email protected] /
[email protected]
📌 Pharmacovigilance Executive (Ahmedabad)
🏢 Torrent Pharmaceuticals
📍 Ahmedabad