Job Description TCS is hiring for Product Safety Lead (PSL)
n Job Location Mumbai - Pune | Bangalore | Hyderabad | Chennai | Indore | Kolkata | Noida
n Role Summary:
n 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.
n 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, robust analytical critical thinking, leadership acumen, and the interpersonal skills required to lead collaborative efforts and navigate complex, often conflicting, organizational priorities.
n Regards
n Manisha Singh (TCS -HR)