Manager - Drug Safety and Risk Management

Lupin Limited is seeking a highly analytical and compliance-driven Manager – Drug Safety and Risk Management to oversee global pharmacovigilance activities, ensuring effective risk management, regulatory compliance, and timely submission of aggregate safety reports. The involves coordinating with cross-functional teams, maintaining risk management systems, and driving continuous improvement in drug safety practices.

Roles & Responsibilities

• Develop and maintain the global aggregate report writing plan to ensure timely submission of safety reports.
• Track and monitor aggregate report timelines and ensure adherence to global regulatory requirements.
• Maintain and update aggregate report compliance trackers with accuracy and completeness.
• Ensure compliance with pharmacovigilance regulations andentify gaps for corrective and preventive actions (CAPA).
• Prepare and review aggregate safety reports such as PSUR, PBRER, DSUR, and other regulatory submissions.
• Maintain and regularly update global and regional risk management measures trackers.
• Ensure effective implementation of Risk Management Plans (RMPs) for products across markets.
• Monitor and evaluate the effectiveness of additional risk minimization measures (aRMMs).
• Coordinate with cross-functional teams including Regulatory Affairs, Marketing, QA, and local affiliates.
• Ensure proper communication and execution of risk management strategies across regions.
• Track commitments related to risk management plans and ensure timely fulfillment.
• Support regulatory inspections and audits by providing necessary safety documentation and reports.
• Analyze safety data trends andentify potential risks associated with products.
• Recommend risk mitigation strategies based on data analysis and regulatory expectations.
• Ensure compliance with global pharmacovigilance guidelines such as ICH, GVP, and local regulations.
• Maintain high standards of documentation, data integrity, and audit readiness.
• Participate in signal detection and risk evaluation activities.
• Provide training and guidance to internal teams on drug safety and risk management practices.
• Collaborate with global stakeholders to align safety processes and reporting standards.
• Drive continuous improvement initiatives in pharmacovigilance systems and processes.
• Ensure timely escalation of safety concerns and implementation of mitigation actions.