Job Details

We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body's immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you're looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

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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Learn More About Agenus

Explore our innovative pipeline and connect with us on LinkedIn.

Why You'll Love Working at Agenus

We're proud to offer a comprehensive and inclusive benefits program designed to support your well-being, growth, and life outside of work:

• 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

What We Believe

• Patients First. We're here to make a difference-for every cancer patient.
• Bold & United. Big goals require strong teams.
• Integrity Always. Respect and honesty guide everything we do.
• Own It. We take responsibility-for results and how we achieve them.
• Always Learning. Curiosity drives innovation.
• Bring Your Best. Every day matters.