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 requests.

Requirements:

• Education: MD
• 4+ years experience in Pharmacovigilance in pharmaceuticals
• Strong knowledge of FDA regulations, PV systems, and safety reporting processes.