Job Details

The Role: Safety Database Manager, Pharmacovigilance Operations

The Safety Database Manager will play a critical role in providing both strategic and hands-on operational PV database support across Agenus' portfolio. This individual will be responsible for overseeing safety database migration and validation efforts, serve as the primary operator of Agenus' Safety Database under the direction of the Head of Safety. Ensure the system is secure, compliant, and optimized to support global safety operations. This pivotal position integrates technical proficiency, effective vendor oversight, and solid regulatory acumen to always ensure adequate safety database performance.

In the role you will:

• Oversee all aspects of the safety database, including daily operations, helpdesk support, vendor relationships, system upgrades, validation activities, dictionary maintenance and reporting processes.
• Act as the primary system operator for the Global Safety Database, responsible for configuration, ongoing maintenance, performance monitoring and user account management, under the direction of the Head of Safety and PV.
• Collaborate with Head of Safety to manage relationships with the safety database system vendor, including oversight of service-level agreements (SLAs), issue resolution, change control, and compliance activities.
• Coordinate system upgrades, validation activities, and release of patches with IT, QA, and the system vendor.
• Generate scheduled and ad hoc reports from the global safety database.
• Responsible for managing user support requests to ensure prompt resolution of issues.
• Coordinate dictionary (MedDRA, WHODD) upgrades with IT, QA and the system vendor
• Create and update system documentation such as user guides, SOPs, and configuration specifications.
• Design, develop, and validate reports to support regulatory submissions, signal detection, safety surveillance and custom reports as needed.
• Monitor and enforce data access controls, security protocols, and audit readiness.
• Support PV audits, inspections (including audit responses), and cross-functional projects.
• Ensure uninterrupted PV operations by collaborating with the system to develop, implement, and test business continuity and disaster recovery plans.
• Provide system training and onboarding for global safety database users.
• Collaborate cross-functionally with internal departments (Data management, Biostats, IT, Quality, Clinical, Regulatory teams etc.) and external stakeholders (global regulatory agencies e.g., FDA, EMA, MHRA, PMDA) to maintain compliance and ensure seamless safety database performance, data integrity and audit readiness.
• Contribute to business planning and operational analyses as appropriate.

Qualifications: About You

• Thorough knowledge of pharmacovigilance workflow, processes and regulations, and skill in translating organizational requirements into effective system solutions.
• BS degree in life sciences, with related PV work experience
• Minimum 6 years of pharmacovigilance experience (at least 5 years managing a global safety database)
• Knowledge of global safety regulations, MedDRA dictionary and its application, WHODD dictionary and its application; and of end-to end case processing and data extraction with global safety databases.
• Experience with PV database migration and validation projects.
• Experience with gateway (ESG) validation with regulatory authorities
• Working with external vendors and service providers.
• Comprehensive knowledge of international pharmacovigilance regulations and ICH standards.
• Skilled in utilizing safety database reporting platforms.
• Familiarity with system validation (CSV), change management practices, and audit preparedness.
• 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.