Pharmacovigilance Executive

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 removed] / [email removed]