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    Medical Safety Writer

    Baxter
    2+ years
    Not Disclosed
    Ahmedabad
    10 Oct. 14, 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 Title: Medical Safety Writer
    Req #: JR - 150058
    Location: Ahmedabad, Gujarat, India
    Job Category: GST Operations
    Date Posted: 10/10/2024

    Join Our Mission at Baxter

    At Baxter, we are united by our commitment to save and sustain lives. Every role at Baxter makes a positive impact, contributing to improved health outcomes for millions globally. With a legacy of over 85 years in medical innovation, our products and therapies are utilized in hospitals, clinics, and homes around the world.

    About the Role

    As a Medical Safety Writer (MSW), you will be instrumental in preparing and completing aggregate safety reports for regulatory submission worldwide. Your responsibilities will include:

    • Writing and preparing standalone post-marketing aggregate safety reports, including:
      • Periodic Adverse Drug Experience Reports (PADERs)
      • Periodic Benefit Risk Evaluation Reports (PBRERs)
      • Periodic Safety Update Reports (PSURs)
    • Performing quality control reviews of these reports.
    • Ensuring compliance with regulatory requirements and internal deadlines.
    • Assisting in the preparation of responses to regulatory authority requests and assessment reports.
    • Collaborating with Drug Safety Physicians, EU-QPPV, and Risk Management teams on safety writing activities.
    • Engaging with other Baxter functional groups, including Regulatory Affairs, Clinical/Medical Affairs, Quality, and Data Management as needed.
    • Supporting the development and maintenance of standardized procedures and processes in Medical Safety Writing.
    • Participating in assigned project teams and committees.

    Reasonable Accommodations

    Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application or interview process due to a medical condition or disability, please let us know your needs along with your contact information.

    Recruitment Fraud Notice

    Be cautious of employment scams posing as Baxter representatives. We encourage you to review our Recruitment Fraud Notice to protect yourself from fraudulent parties attempting to obtain personal or financial information.

    Apply Now to Make a Difference!

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