Local PV Consultant (Remote)
Core
Ensuring local operating company safety activities and product vigilance compliance with regulations and policies at local, regional, and global levels.
Role type
Senior Area Safety Officer Consultant (Pharmacovigilance)
Builds
Product vigilance and risk management systems for pharmaceutical products
Domain
Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
Oversight of PV systems, Vendor resource management, PSMF review and updates, Non-conformance investigation and CAPA development, Safety reporting to health authorities, Cross-departmental reconciliation, Adverse Event literature identification, Document management and archiving, Training oversight
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide oversight of vendor resources in scope countries; Support Area Safety Head in preparing European Economic Area/UK Pharmacovigilance System Master File; Review and update local PSMF; Record and investigate non-conformances; Report local vigilance activities in committees; Respond to health authority safety queries; Reconcile with distributors and third parties; Identify local literature for Adverse Event reporting; Manage document archiving; Ensure documented training
Seniority
Senior, hands-on IC
