Safety Evaluation & Risk Management

Job description

TCS is hiring for Safety Evaluation & Risk Management Role: Safety Physician (Safety Evaluation & Risk Management)

Qualification

MBBS/ MD Experience: Min 3 years’ experience in signal management, safety report authoring and reviewing, Benefit Risk management plan.

Job Responsibilities

Safety Governance and Risk Management activities

• 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.