Medical Reviewer - Kolkata, India - Wipro

    Wipro
    Wipro Kolkata, India

    3 weeks ago

    Wipro background
    Upper Management / Consulting
    Description

    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.