Medical Reviewer (MBBS/ MD)

• Role- Medical Reviewer
• Qualification- MBBS/ MD (MCI Certification mandatory if MBBS/MD from a foreign country)
• Work Mode- Hybrid (Relocation to Pune is mandatory)
• Location- Pune
• Notice Period- Immediate to maximum 15 days

Roles and Responsibilities-

• Medical reviewer will perform the overall medical review, check consistency of the information and provide the causality assessment and company clinical evaluation comment, as appropriate.
• Pharmaceutical industry experience preferred.
• Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements.
• Preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports.
• Knowledge of US and EU regulations and guidelines for pharmacovigilance.
• Ability to independently solve routine problems related to the scope of work being provided and surface issues constructively.
• Demonstrated computer literacy, particularly in the use and management of relational databases
• Ability to make decisions independently in both routine and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impact.
• Ability to discern when additional input/escalation is required to effectively address unique and/or complex situations.
• Ability to work independently to accomplish team goals with minimal supervision.
• Strong skills in productivity, organizational and time management in order to meet strict regulatory compliance goals.
• Ability to achieve personal objectives while meeting departmental standards of performance.