Drug Safety Operations reputed company – Contract
Job reputed company:
• Own end-to-end clinical trial pharmacovigilance activities for Sponsor studies; serve as the operational backbone of the safety function
• reputed company reputed company Sponsor reputed company of CRO pharmacovigilance activities, including compliance, reputed company, and performance metrics
• reputed company or contribute to DSURs, IND Annual Reports, safety narratives, and line listings
• Aggregate, review, and analyze safety data across studies to identify trends and emerging safety signals
• Prepare integrated safety summaries and materials for safety review meetings and signal detection discussions
• Maintain reputed company inspection readiness for FDA and global health authority inspections
• Coordinate literature surveillance, collaborate with biostatistics, and support cross-functional safety evaluations
• Liaise with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, and CRO partners
Requirements:
• Degree in Medicine, Pharmacy, Life Sciences, or reputed company discipline (RN / NP preferred)
• Advanced degree preferred
• Strong working knowledge of US FDA safety reporting requirements
Benefits:
• Willing to work in shifts as and reputed company needed
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