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    Safety Writer

    Vizen Life Sciences
    2-5 years years
    Preffered by Company
    Hyderabad
    10 June 3, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: Safety Writer
    Job ID: JOB006
    Employment Type: Full-Time
    Location: Hyderabad
    Experience Required: 2 - 5 Years

    Job Description: The Safety Writer will be responsible for preparing and reviewing aggregate reports according to guidelines and work instructions.

    Essential Functions:

    • Author and review Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports, ACO, DSUR) for submission to local and other health authorities.
    • Author and review Risk Management Plans (RMPs) as part of regular pharmacovigilance activities.
    • Author and Quality Review of Signal Management Reports.
    • Perform literature searches and validity checks for aggregate reports.
    • Manage and reconcile relevant process trackers.
    • Serve as a Subject Matter Expert (SME), training and mentoring team members.
    • Extract and validate data (RSI, sales, previous reports, RMP, signals).
    • Generate Line Listings (LL) from the safety database.
    • Provide reliable support for high-priority ad-hoc activities.
    • Interact with client personnel to resolve issues related to Aggregate reports in accordance with clients’ policies.
    • Ensure that deliverables comply with relevant regulatory requirements and are delivered within agreed timelines.

    Qualifications:

    • PhD, M-Pharmacy/B-Pharmacy, or Doctor of Pharmacy (PharmD) from a PCI recognized university or college.
    • Preferred: 2-5 years of experience in authoring Aggregate Reports.
    • Proficient in computer operations and keyboarding skills.
    • Proficient with Microsoft Office Suite (Outlook, Word, Excel).
    • Strong verbal, written, and interpersonal communication skills.
    • Excellent organization and prioritization skills, capable of multitasking.
    • Flexible, able to adapt to fluctuating business priorities.
    • Willingness to occasionally work extended and/or flexible schedules to meet client requirements.

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