[Remote] Associate Director, Pharmacovigilance Operations
Note: The job is a remote job and is open to candidates in USA. Agenus is a dedicated group of scientists, physicians, and businesspeople focused on developing therapies for cancer treatment. The Associate Director of Pharmacovigilance Operations will oversee safety database migration, ensure compliance with safety standards, and provide operational support across the oncology-focused portfolio.
Responsibilities
- 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.
Skills
- 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
- Be ready to embrace the principles of the Agenus culture: Innovation and Speed
Education Requirements
- 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
Benefits
- Medical, Dental & Vision Coverage – Competitive options for both US & UK employees
- Flexible Spending Accounts – For healthcare and dependent care expenses (US)
- Flexible Vacation Plan – We believe time away leads to better thinking and innovation.
- Care.com Memberships – Support for family care (US)
- Education Assistance Program – Invest in your learning and development (US)
- 401(k) Match
- Employee Stock Purchase Plan
- Employee Assistance Program (EAP) – Resources for mental health, well-being, and life support
- Reward & Recognition Program – Celebrate contributions that move the mission forward
Company Overview
- Agenus develops and commercializes immunotherapies and vaccines for cancer and infectious diseases. It was founded in 1994, and is headquartered in Lexington, Massachusetts, USA, with a workforce of 201-500 employees. Its website is http://agenusbio.com.
Company H1B Sponsorship
- Agenus has a track record of offering H1B sponsorships, with 4 in 2025, 1 in 2024, 4 in 2023, 7 in 2022, 4 in 2021, 4 in 2020. Please note that this does not guarantee sponsorship for this specific role.
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