Pharmacovigilance Operations Manager

Position Overview 

The Pharmacovigilance (PV) Operations Manager at Immunome is responsible for managing day-to-day global safety operations across Immunome’s clinical stage oncology programs as well as commercial product(s). This role oversees case management activities conducted by external safety vendors, supports clinical study teams on safety matters, and ensures timely and compliant safety reporting in alignment with global regulatory requirements and Immunome’s internal standards.  

As a growing biotechnology organization, Immunome requires an adaptable and highly organized PV Operations Manager who can support cross functional communication, maintain inspection ready safety systems, and drive operational excellence across all PV workflows.  

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.  

• Coordinate 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.  

• 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 fastmoving 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. 

• Adaptability within a growing, innovative biotech environment. 

• High attention to detail and operational rigor.  

• Team-oriented and proactive communicator.