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    Medical Writer Ii

    Parexel
    3-5 years
    Preferred by Comapny
    Mohali
    10 Nov. 25, 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

    Role: Pharmacovigilance Medical Writer
    Job Purpose:
    The Pharmacovigilance Medical Writer is responsible for managing scheduled and unscheduled aggregate reports related to drug safety. This includes preparing and reviewing various regulatory reports, such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and others. The role involves signal detection, managing data discrepancies, and ensuring regulatory compliance. The position also includes preparing narrative reports for Clinical Study Reports (CSRs) and responding to health authority requests, as well as liaising with clients and stakeholders to ensure high-quality and timely deliverables.

    Key Responsibilities

    Aggregate Report Management

    • Prepare and update various aggregate reports such as PSURs, PBRERs, SASRs, PADERs, DSURs, RMPs, and others.
    • Manage the compilation of data for safety reports, including reviewing line listings, health hazard evaluations, and drug safety reports.
    • Conduct critical appraisals of literature, focusing on epidemiology, background incidence, prevalence, and risk factors, to include in safety reports.
    • Generate line listings for submission and identify discrepancies for resolution.
    • Ensure quality checks for data consistency, integrity, and compliance with regulatory standards (FDA, EMA, etc.).
    • Distribute final reports to stakeholders, ensuring timely submission to regulatory bodies.

    Clinical Study Report (CSR) Narratives

    • Coordinate with the Study Management Team (SMT) to develop narrative templates, review drafts, and ensure accurate and clear narratives.
    • Prepare narratives based on clinical and safety data, ensuring they meet client requirements and are in line with Parexel's guidelines.
    • Perform quality checks on drafted narratives and ensure their accuracy and medical cohesiveness.

    Signal Detection and Management

    • Perform signal detection reviews using qualitative and quantitative data from sources like regulatory authorities, client databases, and literature.
    • Lead signal management activities, including tracking, assessment, and evaluation.
    • Collaborate with the Global Safety Operations (GSO) team for signal detection and ensure compliance with internal and regulatory timelines.

    General Responsibilities

    • Maintain a strong knowledge of drug safety profiles, regulatory guidelines, and client-specific requirements.
    • Ensure regulatory compliance for adverse event reporting and clinical study data.
    • Mentor junior team members and assist in their training and development.
    • Prepare reports for audits, inspections, and project-specific reviews.
    • Manage client relationships, ensuring satisfaction and responding to queries in a timely manner.
    • Participate in process improvement initiatives to enhance departmental efficiency.

    Skills and Qualifications

    • Excellent analytical and problem-solving skills, with the ability to evaluate data and draw conclusions.
    • Strong communication and interpersonal skills, both verbal and written.
    • Organizational and prioritization skills, with the ability to manage multiple tasks.
    • Proficiency in IT and web-based applications, and MS Office suite (Word, Excel, PowerPoint).
    • Ability to work collaboratively in a team-oriented, matrix environment.
    • Flexibility and willingness to adapt to new learning and assignments.
    • Strong attention to detail and accuracy in transcription and medical text creation.
    • Client-focused approach, ensuring timely delivery of high-quality work.

    Education and Experience

    • University degree in Life Sciences, Health Sciences, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
    • A degree in Medicine, Dentistry, Physiotherapy, or Nursing would be an advantage.
    • Relevant experience in Regulatory/Pharmacovigilance or a related field is desirable.
    • Good knowledge of medical terminologies and pharmacovigilance practices.

    Why Join?

    • Leadership opportunities for experienced professionals in the pharmacovigilance and medical writingdomain.
    • Collaborative work environment, with exposure to global regulatory guidelines and client relations.
    • Chance to mentor and develop junior writers while managing high-level projects.
    • A rewarding career in a dynamic and ever-evolving field, with opportunities for professional growth and development.

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