About this role
The Manager - Drug Safety and Risk Management leads efforts in aggregate reporting and global risk oversight for pharmaceutical products. This role focuses on planning submissions, ensuring compliance, and tracking risk management measures. It plays a critical part in maintaining safety standards across regions.
Day-to-day responsibilities include preparing and maintaining the aggregate report writing plan to track global submissions. Maintain compliance trackers with corrective and preventive actions, and update global/regional risk management measures trackers regularly. Ensure timely implementation and effectiveness checks of additional risk minimization measures (aRMMs).
Liaise with cross-functional teams like regulatory affairs, marketing, and local affiliates to implement risk management plans effectively. Foster collaboration to meet commitments and track progress. This environment demands stakeholder management and process excellence in a dynamic pharma setting.
Grow through competencies such as developing talent, result orientation, and strategic agility. Opportunities arise in innovation, creativity, and customer centricity within Lupin's global operations. Advance expertise in aggregate reports and risk management with 6-8 years of relevant experience.
Requirements
- Around 6-8 years of experience in Aggregate Reports and Risk Management
- Graduation or Masters in Pharmacy
- Developing Talent
- Result Orientation
- Customer Centricity
- Strategic Agility
- Process Excellence
- Innovation & Creativity
Responsibilities
- Prepare and maintain the aggregate report writing plan to track global aggregate report submissions
- Prepare and maintain the aggregate report compliance tracker and ensure compliance with corrective and preventive actions
- Maintain and regularly update the global/regional risk management measures tracker
- Ensure implementation of additional risk minimization measures (aRMMs) and timely evaluation of their effectiveness for Lupin products globally
- Liaise with cross-functional teams like regulatory affairs, marketing, and local affiliates to implement the risk management plan
- Ensure compliance to risk management commitments and appropriate tracking
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