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 ESSENTIAL DUTIES AND 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)
- 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
Benefits
- Hourly, part-time hourly rate
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What This Job Offers
Job Type
Part-time
Career Level
Manager
Education Level
No Education Listed
Number of Employees
11-50 employees
