Sr. Specialist, DSPV Operations
Core
Supports Pharmacovigilance (PV) Compliance activities and the development/maintenance of the quality management system for global pre- and post-marketing safety.
Role type
Senior Specialist, PV Compliance
Builds
Compliant PV processes and quality management systems
Domain
Biopharmaceuticals / Drug Safety
Deliverable
dashboards & analysis
Required skills
Pharmacovigilance compliance, ICH guidelines, US/EU regulatory requirements, Quality management systems, SOP development, Vendor management, Process improvement, Clinical trial PV, Post-marketing PV, Drug safety databases (Argus)
Preferred skills
Regulatory authority inspection support, Healthcare professional background, Process improvement initiatives
Technologies
MS Excel, Argus
Responsibilities
Manage PV deviations and CAPAs, Track quality/compliance issues, Develop and review SOPs, Support inspection readiness, Collaborate cross-functionally, Interact with PV vendors
Seniority
Senior, hands-on IC