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    Associate Safety Data Management Specialist

    Pfizer
    0-5 years
    Not Disclosed
    Chennai
    10 May 10, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Associate Safety Data Management Specialist

    Company: Pfizer

    Experience: Fresher

    Location: Chennai

    Job Responsibilities:

    • Carry out case processing activities.
    • Review, rank, verify, process, and document case-related information, including event terms, validity, seriousness, timelines, accuracy, and consistency. Process cases based on these assessments.
    • Review case criteria to determine appropriate workflow for case processing.
    • Assess cases to identify complexities or specific issues and escalate them appropriately.
    • Write and edit case narratives.
    • Determine and perform appropriate case follow-up, including generating follow-up requests.
    • Review processed cases to verify accuracy, consistency, and compliance with process requirements.
    • Liaise with key partners locally and other stakeholders regarding safety data collection and data reconciliation.
    • Develop and maintain expertise and knowledge of applicable corporate and global regulations, guidelines, Standard Operating Procedures (SOPs), data entry conventions, and search functions in the safety database.
    • Determine the reportability of scheduled reports, ensuring adherence to regulatory requirements.
    • Consistently apply regulatory requirements and Pfizer policies.
    • Participate in local, internal, and external safety activities.

    Qualification & Experience:

    • Top 10 graduating students of Pharm. D or M. Pharm (Pharmacovigilance/Pharmacology/Pharmacy Practice) or B. Pharm.
    • Prefer students graduating in 2024 over 2023 graduates. Consideration of 2023 graduates is possible if provisional certificates are not received before Jun 2024.
    • Students should have at least one publication in a peer-reviewed journal.

    Work Location Assignment: On Premise

    Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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