You have opted out of job matches in .
To undo this, go to the 'Skills and Interests' section of your preferences.
Shared by 
about 20 hours ago
Requirements and responsibilities
Role OverviewBiogen is going through a system transformation and needs a Senior Manager level candidate to act as a bridge between the Pharmacovigilance department, IT, and Business Analysis.This role is not case processing; it 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 is a very process-driven environment requiring strong problem-solving skills and management of lots of stakeholders across the department and broader environment.ResponsibilitiesProvide business support for 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 needsManage CAPAs and perform root cause investigations as requiredParticipate 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 visualisation reports.Required QualificationsEducationBachelor’s degree in a technical discipline or equivalent combination of education and experience.Experience & Skills2–5 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 rades, 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.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 ase contact us.