Senior Manager, Pharmacovigilance Safety Operations
$170k/y-$200k/y
BioSpacea day ago
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OnsiteFull-timeSenior
Summary
BioSpace is seeking a Senior Manager, Pharmacovigilance Safety Operations to join their team in South San Francisco, CA. The role involves overseeing the reporting, processing, and submission of Individual Case Safety Reports (ICSRs) from clinical trials and ensuring compliance with regulatory requirements.
About the Role
As a Senior Manager, Pharmacovigilance Safety Operations, you will provide operational oversight of ICSR intake and processing, manage vendor relationships, and collaborate with cross-functional teams to ensure timely and compliant safety operations. You will also be responsible for developing safety management plans, coordinating medical reviews, and supporting regulatory submissions.
About You
Required:
- Bachelor’s degree in life sciences, pharmacy, or a related field.
- Minimum of 7+ years of experience in safety operations in the biopharmaceutical industry.
- Strong knowledge of regulatory requirements (e.g., FDA, ICH guidelines) and industry standards related to drug safety.
Preferred:
- Experience with early and late-stage clinical trials (Phase 3) and post-marketing.
- Experience with device safety reporting and regulatory inspections.
- Proficiency in safety databases and software tools (e.g., Oracle Argus, ARISg, MedDRA).
Benefits
- Competitive salary range of $170k–$200k annually.
- Opportunity to work in a fast-paced environment with a focus on innovative solutions.
BioSpace
BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.
South San Francisco, CA