14 Aug
|
Nysa Biomed
|
Satara
14 Aug
Nysa Biomed
Satara
Role & responsibilities
- Implement and maintain the Pharmacovigilance Quality Management System (PVQMS) in compliance with regulatory requirements and company SOPs.
- Coordinate with Regulatory Affairs, Quality Assurance, Product Development, and manufacturing teams for pharmacovigilance and product quality activities.
- Perform in-house testing of current and existing products as per approved SOPs.
- Follow up with manufacturing sites for Certificates of Analysis (CoA), analytical data, and related quality documents.
- Handle market complaints, coordinate investigations, prepare CAPA, and communicate responses to customers.
- Collect and maintain analytical backup documents for new products.
- Maintain control sample records and ensure proper storage, traceability, and retrieval.
- Maintain documentation related to test reports, complaints, investigations, CAPA, and other quality records.
- Coordinate sample submission and testing with approved Private Testing Laboratories (PTLs).
- Monitor and ensure compliance with applicable pharmacovigilance regulations, guidelines, and company policies.
- Prepare and submit periodic MIS reports to management.
- Support product risk management activities and ensure timely implementation of safety and quality actions.
- Perform any other pharmacovigilance and quality-related responsibilities assigned by management.
📌 Pharmacovigilance Executive (Satara)
🏢 Nysa Biomed
📍 Satara