Agenus · 5 hours ago
Manager/Senior Manager, Pharmacovigilance Operations
United States
Full-time
Remote
Mid, Senior Level
4+ years expAgenus is a dedicated group of scientists, physicians, and businesspeople working to discover and develop therapies for cancer. The role involves supporting clinical-stage oncology programs through direct execution of pharmacovigilance activities, including case review, safety document authoring, and signal detection while collaborating with cross-functional teams.
BiotechnologyMedicalMedical DeviceTherapeutics
Hiring Manager
Jeniece Waite
Responsibilities
Perform hands-on review of Individual Case Safety Reports (ICSRs), including assessment of seriousness, expectedness, and regulatory reporting requirements
Author and contribute directly to DSURs, Investigator Brochures (IBs), and other aggregate safety reports, including safety narratives and data interpretation
Conduct and support signal detection and safety trend analyses, including preparation of data listings and participation in safety review meetings
Work directly in the safety database (e.g., Argus/ARISg) to review, QC, and manage safety data
Support day-to-day pharmacovigilance operations, ensuring timely, accurate, and compliant safety reporting
Partner closely with safety vendors, performing quality review of deliverables and following up on queries and timelines
Support SAE reconciliation between clinical and safety databases
Contribute to the development and maintenance of SOPs, Safety Management Plans (SMPs), and work instructions
Collaborate with Medical Safety, Clinical Operations, Data Management, and Regulatory Affairs to ensure consistent and compliant safety data
Participate in safety review committees and study team meetings as an operational PV representative
Support inspection readiness activities, including documentation preparation and response support
Qualification
Required
4–8 years of direct pharmacovigilance or drug safety experience, with a strong emphasis on hands-on execution
Demonstrated experience with: ICSR review and processing, DSUR and IB safety section writing, Signal detection or safety data trending
Working knowledge of GCP, GVP, and ICH guidelines
Experience using global safety databases (Argus, ARISg, or similar)
Ability to work independently in a lean, fast-moving biotech environment
Oncology or immuno-oncology experience
Prior experience supporting clinical-stage programs
Experience contributing to audits or inspections
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
Pharmaceutical Technology
2026-01-17
Company data provided by crunchbase