Pharmacovigilance Executive

Job description

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 riyaraja@torrentpharma.com / vilshashah@torrentpharma.com