Associate Director, Pharmacovigilance Operations
The Role: Associate Director, Pharmacovigilance Operations The Associate Director, Pharmacovigilance (PV) Operations will play a critical role on an agile team, providing both strategic and hands-on operational PV support across Agenus' oncology-focused portfolio. This individual will be responsible for overseeing safety database migration and validation efforts, ensuring accuracy in SAE reconciliation, and driving the review, negotiation, and authorship of Safety Data Exchange Agreements (SDEAs). Working cross-functionally with PV, Regulatory, Medical, Quality, and IT colleagues, the successful candidate will bring deep operational expertise, attention to detail, and the ability to streamline safety operations in a fast-paced biotech environment. In the role you will:
- In collaboration with Regulatory Affairs (RA) and IT, evaluate and oversee PV database migration, configuration, and validation, ensuring compliance with global safety standards.
- Provide day-to-day oversight of safety monitoring and operations activities for clinical trials.
- Ensure timely and compliant case processing operations in collaboration with vendors, including ICSR submissions, SUSAR reporting, and compliance tracking.
- Drive PV compliance metrics, dashboards, and reporting to leadership, ensuring ongoing inspection readiness and regulatory compliance.
- Serve as a PV subject matter expert on cross functions and throughout the company.
- Guide and author PV protocols, IBs, CSRs and other documents including aggregate safety reports [e.g., DSURs, PSURs, etc.].
- Review, negotiate, and author Safety Data Exchange Agreements (SDEAs)/Pharmacovigilance Agreements with business partners.
- Facilitate Safety Review Committee meetings, ensuring Signal Detection oversight to identify risks and drive resolution to identified issues.
- Participate in internal/external audits of global sites/affiliates, processes and vendors with follow-up to include audit resolution/compliance elements.
- Participate and/or Coordinate applicable Governance committee's.
- Contribute to business planning and operational analyses as appropriate.
Qualifications: About You
- Advanced degree in a PV related discipline strongly preferred (PhD, MD, DVM), alternatively a BS/MS degree in a PV related discipline with proven competence in PV would be considered;
- Minimum 6 years of pharmaceutical industry experience (at least 5 years direct PV experience); oncology experience strongly preferred
- Knowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases PV purposes is required.
- Extensive and cross-cutting PV operations background, including case processing, SAE reconciliation, CRF design, protocol review, ICF maintenance, and Safety Data Exchange Agreements (SDEAs).
- Experience working with database administrators on PV database migration and validation projects.
- Experience in the preparation and authoring of pre- and post- aggregate safety reports.
- Experience working with database administrator to achieve database migration and validation.
- Thorough understanding of drug development and safety surveillance activities;
- Ability to work effectively in a collaborative team environment with multiple points of view.
- Independently motivated, detail oriented and good problem-solving abilities are a must.
- Adaptability to rapidly changing priorities within an extremely fast-paced biotech environment is a necessity.
- Assist in the development of annual audit plans (where applicable), SOP's and actively engage in department training plan development and staff training/development; and
- Be ready to embrace the principles of the Agenus culture: Innovation and Speed.
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