Description

The PV Associate supports the Pharmacovigilance Officer in-Charge (PVOIC) in maintaining a compliant Pharmacovigilance system for medicinal products and biologics across assigned territories, including India, Nepal, Bangladesh. The role is responsible for managing safety information, supporting local PV operations, and ensuring compliance with national regulations, global PV requirements, and company policies and procedures. The incumbent will contribute to safety surveillance, risk management, quality system activities, and stakeholder communication while ensuring timely and accurate handling of pharmacovigilance activities.

Key Responsibilities:

• Support the implementation and maintenance of local Pharmacovigilance activities in compliance with applicable regulatory requirements and company procedures.


• Perform review, documentation, tracking, and maintenance of safety information within global safety databases, ensuring timely completion of activities in accordance with regulatory timelines.


• Maintain compliance with Pharmacovigilance Quality Systems, including document management, record retention, archiving, training compliance, and business continuity requirements.


• Support due diligence activities related to third-party agreements and business partners.


• Monitor and identify potential safety concerns, trends, or emerging risks and escalate findings in accordance with established procedures.


• Assist in the implementation of risk minimization measures and other safety risk management activities as appropriate.


• Facilitate communication and escalation of safety-related requests received from regulatory authorities and internal stakeholders to the appropriate Pharmacovigilance contacts.


• Collaborate with local affiliates, Global Patient Safety teams, service providers, and cross-functional stakeholders to support PV operations and compliance activities.


• Respond to queries from country PV teams, Global PV teams, and external service providers in a timely and professional manner.


• Maintain a thorough understanding of company Pharmacovigilance policies, procedures, and regulatory requirements while contributing to continuous process improvement initiatives.