- 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.
