Pharmacovigilance Executive

Torrent Pharmaceuticals; Gandhinagar, Ahmedabad District; On-site; INR 500,000 - 900,000; Full time

Job summary

Torrent Pharmaceuticals in Gandhinagar, Gujarat, India, is seeking a pharmacovigilance professional to maintain SOPs and contribute to a global PV system. The role involves preparing and reviewing PV SOPs, handling ICSR processing, QC and submission, and supporting safety operations across regulatory standards.

Key responsibilities include PSUR, RMP and REMS preparation, signal detection and trend analysis, literature review, handling authority queries, and maintaining the Global AER database.

Qualifications

• 2–7 years of relevant experience.

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

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