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    Senior Drug Safety Physician

    Parexel
    2+ years
    Not Disclosed
    Mohali
    10 Oct. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Purpose:

    The Medical Reviewer will provide medical review, analysis, and guidance throughout the case handling and reporting cycle for Adverse Event (AE) and Adverse Reaction reports related to investigational and marketed products. This role involves offering medical guidance to Drug Safety Associates (DSAs) and specialists, as well as contributing to the narratives for Clinical Study Reports (CSRs).

    General Responsibilities:

    • Maintain a strong working knowledge of the adverse event profiles for assigned products, including labeling documents, data handling conventions, client guidelines, and international drug safety regulations.
    • Stay informed about global regulatory requirements and reporting obligations, ensuring compliance with internal and regulatory timelines for adverse event reporting.
    • Communicate and discuss review process issues with the Project Manager.
    • Interact with internal and external contacts to resolve issues effectively.
    • Participate in client and cross-functional meetings to present findings and insights.
    • Train and mentor new team members as needed, acting as a Subject Matter Expert (SME).
    • Assist the Manager with inspection readiness activities and audits.
    • Provide inputs for process improvements and work closely with the Manager to ensure all KPIs are met.

    Case Report Medical Review:

    • Conduct medical reviews of cases following client Standard Operating Procedures (SOPs) and liaise with clients as necessary.
    • Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assess company causality.
    • Evaluate the seriousness and expectedness of reported events.
    • Provide medical advice to Drug Safety Personnel (DSPs) and the case processing team.
    • Perform literature reviews for product safety assessments and identify potential safety issues.

    Skills:

    • Excellent interpersonal, verbal, and written communication skills.
    • Proficient with computer applications and web-based tools, familiar with the Windows operating system.
    • Client-focused approach with a flexible attitude towards work assignments and learning opportunities.
    • Ability to manage multiple tasks enthusiastically while prioritizing workload with attention to detail.
    • Essential ability to assess the clinical relevance of medical data and interpret its clinical implications.
    • Willingness to work in a matrix environment and appreciate the importance of teamwork.
    • Strong knowledge of international drug regulations, including GCP and GVP.

    Knowledge and Experience:

    • A minimum of 2 years of relevant experience in Pharmacovigilance or drug safety is desirable.

    Education:

    • MBBS or Post Graduation in Medicine, complemented by relevant experience.

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