Role - Drug Safety Physician. Designation - Sr. Executive. Location - Pune. Qualification - MBBS/MD (Pharmacology). Experience - 2 to 7 Years Mode - Work from Office. (Pune) Notice Period - Immediate joiners preferred. CTC- Upto 25 LPA Position Purpose: To Analyze, Review and Interpret Safety data. Primary Responsibilities: To Perform medical review of cases according to Wipro and client specific SOPs and conventions and guidelines in safety database. Provides technical and medical expertise in medical assessments of causality of cases as necessary, including the assessment of quality within the process. Perform quality review of completed or locked cases in safety database as required. Writing of medical assessment comment in safety database Identify process improvement opportunities and drives changes. Contribution to safety and Pharmacovigilance training programs, development of Standard Operating Procedures and Other guidance documents. Demonstrate Knowledge and ensure compliance with current and applicable global Pharmacovigilance regulations and guidelines. Review the Adverse Events case Narrative, coding, Product/Indication, labelling in accordance with the respective reference safety documents, causality and medical history for medical completeness, accuracy and overall medical content. To Review and Provide PV Therapeutic area input for development of protocols, IBs, SAPs documents, if required. Contribute to solving reconciliations medical coding issues or discrepancies. Identifies, communicates, and effectively manages potential safety issues. Perform corrections, route cause and corrective & presentive actions if required Perform other duties as assigned to support PV activities. Additional Responsibilities: Document and track all observations and recommendations in quality feedback tracking tool. Provide appropriate feedback to the Team as and when needed. Support revision/creation of workflow/process documents to optimize and/or improve quality and compliance. Participate in inspections and audits by providing the requested information. Promotion of awareness of procedural and quality requirements within the team. Assistance in preparation or implementation of corrective/preventative actions relating to case processing. Technical Competencies: Knowledge of applicable regulations and guidelines for Pharmacovigilance. Excellent understanding of medical terminology and familiarity with principles of clinical assessment of adverse events in the context of an international pharmaceutical industry. Ability to independently resolve routine problems related to core case processing and surface issues constructively. Demonstrated computer literacy, particularly in the use and management of relational databases. Ability to manage one's own productivity, time management, quality, and compliance in order to achieve acceptable results within given timelines. Ability to achieve personal objectives while meeting departmental standards of performance. Ability to work under supervision in a matrix organization. Ensure training and understanding on case processing SOPs/guidelines/tools. Prioritize cases as appropriate or as directed by Client. Excellent oral and written communication skills with fluency in spoken and written English. Qualification : MBBS or MBBS/MD degree from recognized Indian Medical College or Foreign Medical Graduates Exam (FMGE) Certified Work Experience : 2 years of experience as Medical Reviewer or minimal 1 year of experience in aggregate analysis.