Senior Manager, Pharmacovigilance Operations
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AI Summary
This role involves the direct execution of hands-on Pharmacovigilance activities, including reviewing Individual Case Safety Reports (ICSRs), authoring safety documents like DSURs and IBs, and performing signal detection analysis.
The Role:
We are seeking a hands-on Pharmacovigilance Operations professional to support clinical-stage oncology programs. This role will be responsible for direct execution of PV activities, including case review, safety document authoring, and signal detection, while partnering closely with cross functional teams.
In the role you will:
Core PV Operations
- Perform hands-on review of Individual Case Safety Reports (ICSRs), including assessment of seriousness, expectedness, and regulatory reporting requirements.
- Author and contribute directly to DSURs, Investigator Brochures (IBs), and other aggregate safety reports, including safety narratives and data interpretation.
- Conduct and support signal detection and safety trend analyses, including preparation of data listings and participation in safety review meetings.
- Work directly in the safety database (e.g., Argus/ARISg) to review, QC, and manage safety data.
Operational Execution & Quality
- Support day-to-day pharmacovigilance operations, ensuring timely, accurate, and compliant safety reporting.
- Partner closely with safety vendors, performing quality review of deliverables and following up on queries and timelines.
- Support SAE reconciliation between clinical and safety databases.
- Contribute to the development and maintenance of SOPs, Safety Management Plans (SMPs), and work instructions.
Cross-Functional Collaboration
- Collaborate with Medical Safety, Clinical Operations, Data Management, and Regulatory Affairs to ensure consistent and compliant safety data.
- Participate in safety review committees and study team meetings as an operational PV representative.
- Support inspection readiness activities, including documentation preparation and response support.
Qualifications: About you
- 4–8 years of direct pharmacovigilance or drug safety experience, with a strong emphasis on hands-on execution.
- Demonstrated experience with:
- ICSR review and processing
- DSUR and IB safety section writing
- Signal detection or safety data trending
- Working knowledge of GCP, GVP, and ICH guidelines.
- Experience using global safety databases (Argus, ARISg, or similar).
- Ability to work independently in a lean, fast-moving biotech environment.
- Oncology or immuno-oncology experience.
- Prior experience supporting clinical-stage programs.
- Experience contributing to audits or inspections.
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