Pharmacovigilance Operations Manager

Responsibilities

• Safety Case Management Oversight
• Oversee safety case processing activities performed by Immunome’s PV vendors, including AE/SAE intake, assessment, follow up, MedDRA coding, and regulatory submissions.
• Ensure cases are processed within required timelines and maintain compliance with FDA, EMA, ICH, CIOMS, and other applicable regulations.
• Validate case narratives, source documentation, and sponsor queries submitted by external partners.
• Vendor & CRO Management
• Serve as Immunome’s point of contact for PV operations with contracted partners.
• Monitor vendor performance through periodic metrics review, and compliance dashboards.
• Cook up operational clarifications and ensure prompt resolution of sponsor queries.
• Compliance, Quality, & Inspection Readiness
• Maintain continuous inspection readiness across all safety operations, ensuring complete, accurate, and audit ready documentation.
• Support Health Authority inspections and internal/external audits, including document preparation, responses, and CAPA tracking.
• Contribute to development, revision, and training of Immunome SOPs, work instructions, and PV governance documents.
• Safety Systems & Data Management
• Support data quality checks, reconciliation activities, and system updates.
• Ensure robust data governance practices, including consistency, accuracy, and timely reconciliation with clinical databases.
• Cross Functional Collaboration
• Partner closely with Clinical Operations, Medical Monitoring, Regulatory Affairs, Quality Assurance, and Biometrics to support safety oversight across Immunome clinical programs.
• Provide operational input into Safety Management Plans (SMPs), Safety Data Exchange Agreements (SDEA), and clinical study documents.
• Support preparation of aggregate safety deliverables (e.g., DSURs, SUSAR listings, annual reports) through data coordination and operational QC.
• Project & Documentation Management
• Track PV milestones for multiple clinical programs and ensure timely sponsor review of safety documents (e.g., narratives, CIOMS/MedWatch forms).
• Oversee documentation of operational decision making, vendor communications, and safety process deviations.
• Facilitate safety-related communication with investigators/sites as needed.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related scientific field.
• Advanced scientific or clinical degree preferred.
• A minimum of 5+ years of experience in pharmacovigilance or drug safety, including 2+ years in safety operations leadership or vendor oversight, or equivalent experience.
• Experience in clinical stage biotechnology or oncology programs preferred.
• Strong background in safety databases (Argus, ArisGlobal, or equivalent) and global safety regulations.

Knowledge and Skills

• Deep understanding of PV operations, PV workflows, case processing, MedDRA coding, and regulatory timelines.
• Strong organizational, analytical, and vendor management skills.
• Ability to thrive in a fast-moving biotech environment with evolving pipelines and processes.
• Excellent communication skills with the ability to collaborate cross-functionally and represent PV during internal and external meetings.
• Commitment to patient safety and scientific integrity.
• Strong problem-solving and critical thinking abilities.
• Adaptability within a growing, innovative biotech environment.
• High attention to detail and operational rigor.
• Team-oriented and proactive communicator.

Pay

Washington State Pay Range: $138,310 - $169,890 USD