Biogen
Pharmacovigilance (PV) Systems & Processes Manager
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Location: UK-based (Maidenhead office or fully remote via Teams) Contract length: 1 year
Randstad Sourceright Overview
Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services, is currently recruiting for a PV Scientist Processes and Systems Manager to work for Biogen.
Role Overview
Biogen is undergoing a system transformation and requires a Senior Manager level candidate to bridge the Pharmacovigilance department, IT, and Business Analysis. This role focuses on reviewing data from the process side (reports and documents) to present to regulatory authorities and understanding how data flows through the systems. This environment demands strong problem-solving skills and management of multiple stakeholders across the department and broader environment.
Responsibilities
- Provide business support for the implementation and enhancement of pharmacovigilance safety systems.
- Assist in PV platform upgrades.
- Work closely with Global IT teams for system integrations.
- Serve as a subject matter expert for pharmacovigilance technology solutions.
- Engage with stakeholders to troubleshoot technical issues related to safety databases.
- Manage and maintain Functional Requirements Documents to support the Business needs.
- Manage CAPAs and perform root cause investigations as required.
- Participate in pharmacovigilance audits and regulatory inspections.
- Maintain training materials and controlled system documentation.
- Support user training on newly released systems and functionalities.
- Develop and program reports, KPI dashboards, and data visualization reports.
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Required Qualifications
Education
- Bachelor’s degree in a technical discipline or equivalent combination of education and experience.
Experience & Skills
- 2–5 years of experience with pharmacovigilance safety systems (Big Pharma experience preferred).
- Preferably hands-on experience with Veeva GSD, Veeva Safetydocs, Veeva RIM, or similar PV platforms (or Argus / RSG).
- Experience in safety system implementation, upgrades, and enhancements.
- Knowledge of GxP system validation processes.
- Experience executing User Acceptance Testing (UAT) and requirements gathering.
- Understanding of regulated systems, pharmacology, system architecture, and data flows.
- Strong problem-solving skills, root cause analysis, and CAPAs.
- Strong stakeholder management skills.
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Additional Information
RSR supports applications from a diverse talent pool. We welcome the opportunity to discuss flexibility requirements. If you require any reasonable adjustments to be made to enable you to participate in the recruitment process, please contact us.
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