Manager / Sr. Manager, Pharmacovigilance Systems will manage and oversee the safety database, manage reporting and data outputs from the safety database and other activities to support the PV Department, as determined by PV Management.
- Primary representative and liaison for BBI on the PV database support team, including with the hosting vendor.
- Support the PV team with technical questions regarding the safety database and PV reports
- Create and/or modify PV reports from the PV database to support safety reviews, compliance, vendor oversight, audit requests, health authority inspections and other activities, as needed. Generates listings for aggregate reports, line listings, signaling reports, and audit/inspections
- Develop and maintain process documents associated with the PV Database.
- First line of support for PV database and PV reports, escalates issues and collaborates with hosted vendor and/or support team for database issues.
- Entering, tracking and monitoring PV database service tickets and ensuring timely and adequate follow-up from the hosting vendor.
- Oversee, manage and conduct UAT testing as needed for any PV system.
- Maintains knowledge of adverse event reporting process and the safety system and contributes to the development, improvement and standardization of new processes and methods.
- Undertake activities necessary to support and maintain a state of inspection readiness.
- Support changes to the systems including configuration changes and system upgrades.
- Coordinates and/or direct the work activities of staff or other team members on project-oriented tasks.
- Assesses and analyzes business requirements and recommends solution and plan.
- During system implementation and change management, supports, tests, and refines application configurations to align with business process needs.
- Works with business and IT partners to enhance applications to reduce operating time or improve efficiency.
- All other ad hoc assignments as required.
- Bachelor's degree in health sciences, computer science, information systems or related field or relevant combination of education and experience required.
- 5+ years' experience in the biotech/pharmaceutical industry within drug safety/Pharmacovigilance.
- Experience working with PV safety databases/other database systems and safety data visualization systems required (Argus preferred).
- Previous experience in assistance with User Acceptance Training, database workflow structure and computer system validation required.
- Proficient in Microsoft Office.
- Broad understanding of relevant US, EU and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments is desirable.
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org