What are the responsibilities and job description for the Pharmacovigilance Manager position at JCW Group?
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.
Salary : $95 - $115