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    Aggregate Report Coordinator

    Pfizer
    1-5 years
    Not Disclosed
    Chennai
    10 July 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, 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

    Position: Safety Aggregate Report Project Manager

    Position Purpose: The Safety Aggregate Report Project Manager is responsible for overseeing the project management of safety aggregate reports submitted to regulators such as the FDA and EMA. This role involves collaboration with colleagues from safety, clinical, regulatory, and other functional areas to produce and ensure timely and compliant aggregate reports.

    Primary Responsibilities:

    • Lead the preparation of safety aggregate reports from initiation to submission, working closely with key stakeholders in Clinical, Regulatory, Safety, DevOps, Submissions, and other departments.
    • Review data for consistency across various contributors.
    • Compile report information using electronic tools and document management systems.
    • Coordinate the review and approval process of reports, addressing any review comments.
    • Ensure reports are completed and submitted before regulatory due dates to maintain compliance.
    • Provide guidance to contributors regarding report requirements.
    • Participate in projects or subject matter tasks that support group deliverables.
    • Engage in developing and performing User Acceptance Testing (UAT) as needed.
    • Complete training in line with Pfizer’s and WSR Safety Information Management curriculum.

    Technical Skill Requirements:

    • Experience in the pharmaceutical industry, clinical research, or a healthcare-related field.
    • Proficiency with Microsoft Word, Excel, Adobe Acrobat, and similar tools.
    • Familiarity with SharePoint technology (e.g., Microsoft InfoPath, SharePoint Designer).
    • Experience with Business Objects is a plus.

    Qualifications:

    • Bachelor’s Degree in life sciences, healthcare, or a pharmaceutical discipline required.
    • Excellent verbal and written communication and presentation skills in English.
    • Detail-oriented with strong project management and issue resolution skills.
    • Demonstrated ability to perform effectively in a cross-functional environment.
    • Knowledge of regulatory and safety regulations and guidelines desired.

    Work Location: Flexible

    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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