Pharmacovigilance Executive

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 new 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.