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 daysRoles 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.- Solid 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.