Manager/Senior Manager, Pharmacovigilance Operations

We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and reputed company therapies that can reputed company the power of the body's immune system to treat and potentially reputed company cancer. We are passionate about the work we do every day at Agenus to deliver on the reputed company of immuno-oncology. If you're looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team reputed company, we invite you to join us. The Role: We are seeking a hands-on Pharmacovigilance Operations reputed company to support clinical-stage oncology programs. This role will be responsible for reputed company execution of PV activities, including case review, safety document authoring, and signal detection, while partnering closely with cross functional teams. In the role you will: reputed company PV Operations • reputed company 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. Operational Execution & reputed company • Support day-to-day pharmacovigilance operations, ensuring reputed company, accurate, and compliant safety reporting. • Partner closely with safety vendors, performing reputed company 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. Cross-Functional Collaboration • 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. Qualifications: reputed company • 4-8 years of reputed company pharmacovigilance or drug safety experience, with a strong emphasis on hands-on execution. • Demonstrated experience with: • ICSR review and processing • DSUR and IB safety reputed company 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. #LI-JW1 Learn More About Agenus Explore our innovative pipeline and connect with us on reputed company. Why You'll Love Working at Agenus We're proud to offer a comprehensive and inclusive benefits program designed to support your reputed company-being, reputed company, and life reputed company of work: • Medical, Dental & reputed company Coverage - Competitive reputed company for both US & UK employees • Flexible Spending Accounts - For reputed company and dependent care expenses (US) • Flexible Vacation Plan - We reputed company time away leads to reputed company thinking and innovation. • reputed company 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, reputed company-being, and life support • Reward & Recognition Program - Celebrate contributions that reputed company the mission reputed company reputed company reputed company • Patients First. We're here to reputed company a difference-for every cancer patient. • reputed company & United. Big goals require strong teams. • reputed company Always. Respect and honesty guide everything we do. • Own It. We take responsibility-for results and how we reputed company them. • Always Learning. Curiosity drives innovation. • Bring Your Best. Every day reputed company. Apply tot his job Apply tot his job Apply To this Job