Manager/Senior Manager, Pharmacovigilance Operations
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:
We are seeking a hands-on Pharmacovigilance Operations professional to support clinical-stage oncology programs. This role will be responsible for direct 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:
Core PV Operations
• 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.
Operational Execution & Quality
• 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.
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: About you
• 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.
#LI-JW1
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.
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The Role:
We are seeking a hands-on Pharmacovigilance Operations professional to support clinical-stage oncology programs. This role will be responsible for direct 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:
Core PV Operations
• 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.
Operational Execution & Quality
• 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.
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: About you
• 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.
#LI-JW1
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.
Apply tot his job
Apply To this Job