Safety Physician

TCS is hiring for Safety Physician!!!

Job Location Mumbai, Pune, Bangalore

Experience Range 1- 2 Years

Educational Qualification(s) Required MBBS, MD

Roles & Responsibilities

Conducts, or leads with guidance, pharmacovigilance and risk management planning for designated products.

Contributes to regulatory benefit-risk assessments and prepares the regional Risk Management Plans for designated products In partnership with the product scientist, provides clinical safety input into Clinical Development planning activities

Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues.

Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters. May present safety information at clinical investigator and commercial meetings.

Ensures prompt notification to TA Head of reviewed protocols that are identified as potential PASS Facilitates establishment of Safety Review Teams as necessary, provides data for review and actively contributes to interpretation and discussion. May chair a Safety Review Team with guidance. Ensures that risk-reduction strategies are implemented appropriately in relevant documents such as clinical study protocols and/or product labelling Provides medical input for risk evaluation and risk management planning