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    Drug Safety Associate Ii - Psur Report Authoring And Review

    Vizen Life Sciences
    2-6 years
    Not Disclosed
    India
    10 July 26, 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, 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: PSUR Specialist

    Key Responsibilities:

    • Authoring and Reviewing PSURs:

      • Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities.
      • Ensure the accuracy, completeness, and regulatory compliance of all PSURs.

    • Literature Search and Validation:

      • Conduct literature searches to gather relevant data for PSUR preparation.
      • Validate information from literature searches to ensure its accuracy.

    • Data Management:

      • Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP).
      • Generate Line Listings (LL) from the safety database for inclusion in PSURs.

    • Process Management:

      • Manage and reconcile relevant process trackers to ensure all activities are documented and on schedule.
      • Provide reliable support for high-priority ad-hoc activities related to PSUR preparation.

    • Client Interaction:

      • Communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies.
      • Ensure PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines.

    • Subject Matter Expertise and Training:

      • Serve as a subject matter expert (SME) for PSUR preparation and review.
      • Provide training and mentoring to team members on PSUR-related processes and regulatory requirements.

    Qualifications:

    • Bachelor’s degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). Advanced degree preferred.
    • Experience in pharmacovigilance, drug safety, or a related field, with a focus on PSUR preparation and review.
    • Knowledge of regulatory requirements for PSURs/PBRERs.
    • Strong analytical and problem-solving skills with the ability to evaluate and interpret complex safety data.
    • Excellent written and verbal communication skills.
    • Proficiency in safety databases and data extraction/validation processes.
    • Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.
    • Demonstrated ability to collaborate effectively with cross-functional teams and provide expert guidance.

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