Associate Director - Product Manager, PV Reporting and Surveillance
Core
Lead the development and implementation of pharmacovigilance strategies, processes, and systems to ensure regulatory compliance and patient safety within a pharmaceutical R&D division.
Role type
Associate Director, Product Manager (Pharmacovigilance)
Builds
PV systems for adverse event reporting and signal detection
Domain
Pharmaceuticals / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Pharmacovigilance strategy, PV system management, Global PV regulations (ICH), Stakeholder management, Product roadmap planning, Vendor management, Agile application development, Cloud architecture, Project management, Patient safety processes
Preferred skills
Veeva Vault Safety, 21-CFR-Part-11, Risk-based monitoring, Medical affairs knowledge
Technologies
Veeva Workbench, Veeva Vault Safety, Cloud platforms
Responsibilities
Develop and implement PV strategies meeting regulatory requirements; Manage and prioritize the backlog of changes; Maintain up-to-date knowledge of global PV regulations; Ensure PV processes comply with ICH guidelines; Collaborate with clinical, regulatory, and safety departments; Partner with business technology to implement new PVQC systems.
Seniority
Senior, hands-on IC with leadership responsibilities
