Drug Safety Operations Lead – Contract
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Job Description
Drug Safety Operations Lead overseeing pharmacovigilance activities for clinical trials. Responsible for compliance, quality oversight, data analysis, and collaboration across functions.
Responsibilities:
- 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
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