Medical Reviewer

3 weeks ago

Kolkata, India Wipro Full time

Wipro is hiring for Drug Safety Physician-Medical Reviewer for Kolkata Location


Apply only if ready to relocate to Kolkata/ from Kolkata.


Position Purpose: To Analyze, Review and Interpret Safety data.


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.


Designation- Assistant Manager


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.

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