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    Medical Writer Ii

    Parexel
    2+ years
    Not Disclosed
    Bengaluru Hyderabad
    10 March 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Medical Writer II
    Location: SAS Nagar (Mohali), India
    Additional Locations: Bengaluru, Karnataka, India; Hyderabad, Telangana, India; SAS Nagar (Mohali), Punjab, India

    Job Purpose:

    Responsible for managing scheduled and unscheduled aggregate reports, including but not limited to:

    • Periodic Safety Reports (PSRs)
    • Periodic Safety Update Reports (PSURs)
    • Periodic Benefit-Risk Evaluation Reports (PBRERs)
    • Addendum to Clinical Overviews (ACOs)
    • Semi-Annual Safety Reports (SASRs)
    • Corporate Addendum Reports
    • United States Periodic Adverse Drug Experience Reports (PADERs)
    • Development Safety Update Reports (DSURs)
    • Annual Risk-Benefit Evaluation (ARBE) Report
    • Risk Management Plan (RMP)
    • Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs)
    • Preparing document comparisons between local and global labeling (if applicable)
    • Checking International Non-proprietary names (INNs) for inclusion in a PSR
    • Signal detection and management (where applicable)

    Key Responsibilities:

    Aggregate Reports:

    • Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs).
    • Preparing health authority response documents and RMS updates.
    • Conducting systematic literature reviews to include epidemiological data in drug safety reports.
    • Developing literature search strategies for safety reports.
    • Applying epidemiological methods to assess data in literature.
    • Generating line listings for submissions and ensuring resolution of discrepancies.
    • Performing compliance activities including quality review of various aggregate reports.
    • Distributing final reports to stakeholders and submitting to health authorities.
    • Scheduling and coordinating meetings, drafting agendas and minutes, tracking action items.

    Clinical Study Report Narratives:

    • Coordinating with the Study Management Team (SMT) for narrative template development.
    • Serving as the primary client contact for narrative writing.
    • Preparing accurate narratives based on clinical and safety database outputs.
    • Performing quality checks and ensuring cohesiveness in narratives.
    • Supporting CSR narrative review with SMT.

    Signal Detection and Management:

    • Performing signal detection reviews and qualitative/quantitative analysis.
    • Leading the end-to-end signal management process.
    • Supporting signal detection and evaluation activities in line with SOPs.

    General Responsibilities:

    • Maintaining a thorough understanding of adverse event safety profiles, regulations, and guidelines.
    • Ensuring compliance with internal and regulatory timelines.
    • Participating in audits and inspections.
    • Striving for client satisfaction based on feedback.
    • Mentoring new team members as needed.
    • Archiving source documents and responding to client queries in a timely manner.
    • Participating in process improvement and training initiatives.

    Skills & Competencies:

    • Analytical and problem-solving skills.
    • Excellent communication skills (verbal and written).
    • Strong organizational and prioritization abilities.
    • Attention to detail and accuracy in documentation.
    • Ability to work collaboratively in a team.
    • Client-focused approach to work.
    • Strong knowledge of medical terminology.
    • Fluency in English (written and spoken).
    • Proficiency in MS Office and web-based applications.
    • Awareness of global regulatory requirements.

    Knowledge & Experience:

    • Experience in Regulatory/Pharmacovigilance or a related field preferred.
    • Strong knowledge of medical terminology.

    Education:

    • Required: University degree in Life Sciences, Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
    • Preferred: Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing (with hospital-based exposure).

     

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