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    Medical Writer Ii

    Parexel
    2+ years
    Not Disclosed
    Mohali
    10 Sept. 7, 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: Aggregate Report and Clinical Study Report Specialist

    Job Purpose:

    The Aggregate Report and Clinical Study Report Specialist is responsible for managing both scheduled and unscheduled aggregate reports, including Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), and Clinical Study Reports (CSRs). The role involves preparing and reviewing a variety of safety and regulatory documents, coordinating with study teams, performing signal detection and management, and ensuring compliance with client and regulatory requirements.

    Key Accountabilities:

    Aggregate Reports Management:

    • Preparation and Review: Manage and prepare various aggregate reports, including PSURs, PBRERs, ACOs, SASRs, and other related documents. Ensure compliance with client specifications, regulatory standards, and Standard Operating Procedures (SOPs).
    • Data Analysis: Conduct critical appraisals and systematic reviews of literature for background epidemiology. Develop literature search strategies and apply epidemiological methods to support the safety reports.
    • Quality Control: Perform quality reviews to verify data consistency and integrity across aggregate reports. Revise documents based on feedback and ensure high-quality deliverables.
    • Submission and Tracking: Generate line listings, create drug lists/folders, perform regulatory submissions, test electronic submission gateways, and track compliance monitoring.

    Clinical Study Report Narratives:

    • Coordination: Liaise with Study Management Teams (SMT) to develop narrative templates and review narratives as required. Serve as the primary client contact for narrative writing, addressing issues and negotiating timelines.
    • Narrative Preparation: Prepare clear and accurate narratives based on clinical and safety database outputs. Ensure medical cohesiveness and compliance with client and internal guidelines.
    • Quality Assurance: Conduct final quality control checks, compile, and format narratives for submission.

    Signal Detection and Management:

    • Detection and Analysis: Perform qualitative and quantitative signal detection reviews from various sources, including regulatory databases and literature. Manage the end-to-end signal management process, including tracking, assessment, and presenting findings.
    • Collaboration: Work with the Global Safety Operations (GSO) team to conduct and support signal detection and evaluation activities according to SOPs and guidelines.

    General Responsibilities:

    • Regulatory Knowledge: Maintain a thorough understanding of drug safety profiles, labeling documents, client guidelines, and international drug safety regulations. Ensure compliance with reporting obligations and internal timelines.
    • Training and Mentoring: Attend and conduct training sessions. Mentor new recruits and provide project-specific training as needed.
    • Client Liaison: Serve as the primary client contact, addressing queries, managing feedback, and ensuring client satisfaction.
    • Documentation and Reporting: Archive source documents and relevant communications. Prepare for and participate in audits and inspections.

    Skills:

    • Analytical and Problem-Solving: Strong ability to analyze data, draw conclusions, and address complex issues independently.
    • Communication: Excellent verbal and written communication skills, with the ability to produce clear and concise medical text.
    • Organizational: Highly organized with the ability to manage multiple tasks, prioritize effectively, and maintain attention to detail.
    • Technical Proficiency: Proficient in Microsoft Office (Word, Excel, PowerPoint), with the ability to work with web-based applications and the Windows Operating System.
    • Client-Focused: A client-focused approach with the ability to build and maintain professional relationships.

    Knowledge and Experience:

    • Regulatory/Pharmacovigilance Experience: Relevant experience in regulatory or pharmacovigilance roles, with a strong understanding of medical terminologies and safety reporting.
    • Epidemiology and Data Analysis: Experience with epidemiological methods and data analysis for safety reporting is desirable.

    Education:

    • Minimum Qualification: A university degree in Life Sciences, Health, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology).
    • Preferred Qualification: A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with patient exposure is advantageous.

    Additional Requirements:

    • Fluency in written and spoken English.
    • Ability to work in a matrix environment and adapt to global cultures.
    • Capability to handle confidential information professionally and respond to client needs promptly.

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