Clinical Specialist

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.