Pharmacovigilance Operations Manager
Immunome, Inc.
June 25, 2026
Remote friendly (Bothell, WA)
United States
$138,310 - $169,890 USD yearly
Operations
Position Overview
The Pharmacovigilance (PV) Operations Manager manages day-to-day global safety operations across clinical-stage oncology programs and commercial products, overseeing safety case management by external vendors, supporting clinical teams on safety matters, and ensuring timely, compliant safety reporting aligned with global regulations and internal standards.
Responsibilities
- Oversee safety case processing (AE/SAE intake, assessment, follow-up, MedDRA coding, regulatory submissions).
- Ensure cases meet required timelines and comply with FDA, EMA, ICH, CIOMS, and other regulations.
- Validate case narratives, source documentation, and sponsor queries from external partners.
- Serve as PV point of contact for contracted vendors/CROs.
- Monitor vendor performance via metrics and compliance dashboards; resolve sponsor queries.
- Maintain inspection readiness; support health authority inspections and audits (document prep, responses, CAPA tracking).
- Develop/revise/train SOPs, work instructions, and PV governance documents.
- Support data quality checks, reconciliation, and system updates; ensure data governance with timely reconciliation to clinical databases.
- Collaborate with Clinical Operations, Medical Monitoring, Regulatory Affairs, QA, and Biometrics; provide input to SMPs/SDEAs and safety documents.
- Coordinate aggregate safety deliverables (e.g., DSURs, SUSAR listings, annual reports) and operational QC.
- Track PV milestones; oversee documentation of decisions, vendor communications, and safety deviations; facilitate investigator/site safety communications.
Qualifications
- Bachelor’s or Master’s in Life Sciences, Pharmacy, Nursing, or related field.
- Advanced scientific or clinical degree preferred.
- 5+ years in pharmacovigilance/drug safety, including 2+ years in safety operations leadership or vendor oversight.
- Experience in clinical-stage biotechnology/oncology preferred.
- Strong background in safety databases (Argus, ArisGlobal, or equivalent) and global safety regulations.
Skills
- Deep PV operations/workflows, case processing, MedDRA coding, and regulatory timelines.
- Strong organizational/analytical/vendor management skills; excellent cross-functional communication.
- Problem-solving, critical thinking, attention to detail, operational rigor, adaptability, patient safety focus, proactive team orientation.
The Pharmacovigilance (PV) Operations Manager manages day-to-day global safety operations across clinical-stage oncology programs and commercial products, overseeing safety case management by external vendors, supporting clinical teams on safety matters, and ensuring timely, compliant safety reporting aligned with global regulations and internal standards.
Responsibilities
- Oversee safety case processing (AE/SAE intake, assessment, follow-up, MedDRA coding, regulatory submissions).
- Ensure cases meet required timelines and comply with FDA, EMA, ICH, CIOMS, and other regulations.
- Validate case narratives, source documentation, and sponsor queries from external partners.
- Serve as PV point of contact for contracted vendors/CROs.
- Monitor vendor performance via metrics and compliance dashboards; resolve sponsor queries.
- Maintain inspection readiness; support health authority inspections and audits (document prep, responses, CAPA tracking).
- Develop/revise/train SOPs, work instructions, and PV governance documents.
- Support data quality checks, reconciliation, and system updates; ensure data governance with timely reconciliation to clinical databases.
- Collaborate with Clinical Operations, Medical Monitoring, Regulatory Affairs, QA, and Biometrics; provide input to SMPs/SDEAs and safety documents.
- Coordinate aggregate safety deliverables (e.g., DSURs, SUSAR listings, annual reports) and operational QC.
- Track PV milestones; oversee documentation of decisions, vendor communications, and safety deviations; facilitate investigator/site safety communications.
Qualifications
- Bachelor’s or Master’s in Life Sciences, Pharmacy, Nursing, or related field.
- Advanced scientific or clinical degree preferred.
- 5+ years in pharmacovigilance/drug safety, including 2+ years in safety operations leadership or vendor oversight.
- Experience in clinical-stage biotechnology/oncology preferred.
- Strong background in safety databases (Argus, ArisGlobal, or equivalent) and global safety regulations.
Skills
- Deep PV operations/workflows, case processing, MedDRA coding, and regulatory timelines.
- Strong organizational/analytical/vendor management skills; excellent cross-functional communication.
- Problem-solving, critical thinking, attention to detail, operational rigor, adaptability, patient safety focus, proactive team orientation.