Agenus · 1 day ago
Associate Director, Pharmacovigilance Operations
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
6+ years expAgenus is a dedicated group of scientists, physicians, and businesspeople working towards developing therapies for cancer treatment. The Associate Director of Pharmacovigilance Operations will oversee safety database migration, ensure compliance in case processing, and drive operational support across the oncology-focused portfolio, collaborating with various teams to streamline safety operations.
BiotechnologyMedicalMedical DeviceTherapeutics
Hiring Manager
Jeniece Waite
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
Qualification
Required
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
Be ready to embrace the principles of the Agenus culture: Innovation and Speed
Preferred
Oncology experience strongly preferred
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
Agenus
Agenus develops and commercializes immunotherapies and vaccines for cancer and infectious diseases.
201-500 employees
H1B Sponsorship
Agenus has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (4)
2022 (7)
2021 (4)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$382.14MKey Investors
Zynext VenturesLigand Pharmaceuticals
2025-06-03Post Ipo Equity· $16M
2024-11-27Post Ipo Debt· $20M
2024-05-07Post Ipo Debt· $75M
Leadership Team
Robin Taylor
Chief Commercial Officer
Recent News
2025-12-24
Company data provided by crunchbase