Drug Safety Operations Lead – Contract
Job Description:
• Own end-to-end clinical trial pharmacovigilance activities for Sponsor studies; serve as the operational backbone of the safety function
• Provide active Sponsor oversight of CRO pharmacovigilance activities, including compliance, quality, and performance metrics
• Lead 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 continuous 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 related discipline (RN / NP preferred)
• Advanced degree preferred
• Strong working knowledge of US FDA safety reporting requirements
Benefits:
• Willing to work in shifts as and when needed
Apply tot his job
Apply To this Job
• Own end-to-end clinical trial pharmacovigilance activities for Sponsor studies; serve as the operational backbone of the safety function
• Provide active Sponsor oversight of CRO pharmacovigilance activities, including compliance, quality, and performance metrics
• Lead 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 continuous 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 related discipline (RN / NP preferred)
• Advanced degree preferred
• Strong working knowledge of US FDA safety reporting requirements
Benefits:
• Willing to work in shifts as and when needed
Apply tot his job
Apply To this Job