• Prepare and review aggregate safety reports including PSUR, PADER, DSUR, and RMP
• Ensure compliance with global pharmacovigilance regulations (ICH, EMA, US FDA)
• Perform medical review and safety data analysis for periodic reports
• Coordinate with cross-functional teams to ensure timely submissions
• Maintain documentation in line with SOPs and regulatory timelines
• Support audits and regulatory inspections as required
• Degree in Pharmacy (B.Pharm / M.Pharm)
• 1–3 years of experience in aggregate safety report writing
• Strong knowledge of pharmacovigilance processes and global safety reporting
• Hands-on experience with PSUR, PADER, DSUR, and RMP
• Excellent medical writing and analytical skills
• Strong communication and coordination abilities
• Ability to work independently and meet strict regulatory deadlines
Lambda Therapeutics is a growing pharmaceutical organization engaged in drug development and global regulatory activities. The company offers professionals exposure to international pharmacovigilance standards, collaborative cross-functional teams, and strong opportunities for career development in drug safety and regulatory writing.
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