About this role
Sitero is an emerging leader in clinical services and software solutions for the life sciences industry. The Drug Safety Operations Lead serves as the operational backbone of the safety function, owning end-to-end clinical trial pharmacovigilance activities for sponsor studies. This role emphasizes ethics, compliance, and innovation across early phase to Phase III trials.
Day-to-day involves providing active sponsor oversight of CRO pharmacovigilance activities, including compliance, quality, and performance metrics. Lead contributions to DSURs, IND Annual Reports, safety narratives, and line listings. Aggregate, review, and analyze safety data to identify trends and emerging signals.
Prepare integrated safety summaries for review meetings and signal detection discussions. Coordinate literature surveillance and collaborate with biostatistics for cross-functional evaluations. Liaise with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, and CRO partners.
Maintain continuous inspection readiness for FDA and global health authority inspections. The role supports high-touch services ensuring stakeholder safety in the clinical research community. Part-time contract offers flexibility with hours as needed, including shifts.
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
- Experience in clinical trial pharmacovigilance operations
- Familiarity with sponsor oversight of CRO safety activities
- Knowledge of safety data aggregation and signal detection
- Understanding of DSURs, IND Annual Reports, and related safety documents
Responsibilities
- Own end-to-end clinical trial pharmacovigilance activities for sponsor studies; serve as 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
- Remote, US-based flexibility
- Hourly, part-time compensation
- Hours as needed with shift flexibility
- Equal opportunity employer
Similar roles
Senior Scientist - Drug Safety (Pharmacovigilance)
1w1 week agoCentessa Pharmaceuticals plc
Boston, US · Full-time · $145,000 – $190,000
Senior Clinical Trial Manager - Remote
1w1 week agoAbbVie
Madrid, ES · Full-time · €70,000 – €100,000
Clinical Project Manager - Remote
1w1 week agoClario
CR · Full-time · $105,000 – $135,000
Local Pharmacovigilance Specialist
1w1 week agoAmerisourceBergen
DE · Full-time · €60,000 – €85,000