03 Aug
|
Nysa Biomed
|
Maharashtra
03 Aug
Nysa Biomed
Maharashtra
Role & responsibilities
Job Description:
* 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 recent 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 (Maharashtra)
🏢 Nysa Biomed
📍 Maharashtra