Pharmacovigilance Associate

Primary Responsibilities:

1. General Responsibilities and Regulatory Compliance:

• Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
• Monitor national pharmacovigilance legislation.
• Ensure appropriate interpretation and implementation of national pharmacovigilance regulation for both

drugs and devices.

• Responsible for liaising with the Ministry of Health (MoH)/national regulatory authority (RA), work with legal, quality, medical and regulatory on safety issues if necessary.
• Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
• Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
• Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
• Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.

Job Type: Full-time

Pay: ₹35,000.00 - ₹45,000.00 per month

Benefits:

• Internet reimbursement