Associate Director - Product Manager, PV Reporting and Surveillance
Core
Lead the development and implementation of pharmacovigilance strategies, processes, and systems to ensure patient safety, quality, and regulatory compliance in a pharmaceutical R&D environment.
Role type
Senior Product Manager (Pharmacovigilance & IT Systems)
Builds
PV reporting and surveillance software systems, global safety case intake, processing, and management workflows.
Domain
Pharmaceuticals / Life Sciences / Regulatory Compliance
Required skills
Pharmacovigilance strategy, Regulatory compliance (ICH, 21-CFR-Part-11), Stakeholder management, Product roadmap planning, Agile development, Cloud architecture, Vendor management, Data integrity, Cross-functional collaboration
Preferred skills
Veeva Vault Safety, Signal detection, Risk-based monitoring, Medical affairs knowledge
Technologies
Veeva Workbench, Veeva Vault Safety Docs, Cloud platforms, Agile tools
Responsibilities
Develop and implement PV strategies meeting regulatory requirements; Manage PV system backlog and roadmap; Ensure compliance with global PV regulations; Collaborate with clinical, regulatory, and safety departments; Partner with business technology to implement new PVQC systems.
Seniority
Senior, hands-on IC with strategic leadership