TCS is hiring for Product Safety Lead (PSL)
Job Location Mumbai - Pune | Bangalore | Hyderabad | Chennai | Indore | Kolkata | Noida
Role Summary:
The Product Safety Lead (PSL) is responsible for the comprehensive safety strategy and benefit-risk decision-making for assigned established products throughout their lifecycle for an Innovator Pharma client. As the primary subject matter expert for end-to-end PV activities, the PSL maintains and updates the safety profile of molecules, ensuring proactive risk management, cross-functional stakeholder engagement, and transparent communication with regulatory authorities. This role is central to maximizing patient safety while aligning safety deliverables with the broader business and portfolio strategy.
Beyond scientific oversight,
the PSL serves as a matrix leader who must influence cross-functional teams and internal stakeholders to ensure safety considerations remain central to decision-making. They are responsible for delivering critical clinical safety reports, managing signal evaluations/assessments, and providing expert guidance for aggregate reports and regulatory submissions. Successful candidates must possess a blend of advanced scientific or medical expertise, solid analytical critical thinking, leadership acumen, and the interpersonal skills required to lead collaborative efforts and navigate complex, often conflicting, organizational priorities.
Regards
Manisha Singh (TCS -HR)