Responsibilities. Oversee adverse event reporting (ICSRs, PADERs) and aggregate safety submissions. Support audits, inspections, CAPA management, and safety data exchange agreements. Collaborate with internal teams and PV vendors to ensure data accuracy and compliance. Maintain local PV files, SOPs, and training documentation. Provide PV support for clinical and post-market activities. Assist with medical information inquiries and regulatory requ...
