Pharmacovigilance Executive

Nysa Biomed; Satara; On-site; INR 600,000 - 900,000; Full time

Job summary

Nysa Biomed in Satara, Maharashtra is seeking a Pharmacovigilance Quality Management professional to implement and maintain PVQMS in line with regulatory requirements and SOPs. You will coordinate across Regulatory Affairs, QA, Product Development and manufacturing to support pharmacovigilance and product quality activities.

Key tasks include in-house testing, follow-up for CoA and analytical data, handling complaints, coordinating investigations, and preparing CAPA with clear management

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 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.

Job description

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.