Drug Safety Operations Lead (Contract)
About The Position
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Job Title: Drug Safety Operations Lead Location: Remote, US Based Function: Drug Safety / Pharmacovigilance
Requirements
- Degree in Medicine, Pharmacy, Life Sciences, or related discipline (RN / NP preferred)
- Strong working knowledge of US FDA safety reporting requirements
Nice To Haves
- Advanced degree preferred
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
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What This Job Offers
Job Type
Part-time
Education Level
No Education Listed
