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    Drug Safety Associate

    Novotech
    2+ years
    Not Disclosed
    India
    10 Sept. 10, 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

    Position Title: Drug Safety Associate

    Position Overview: The Drug Safety Associate is responsible for the complete and accurate processing of adverse event reports in compliance with company SOPs, internal business practices, and global regulatory requirements. This role ensures adherence to worldwide safety regulations and supports the safety reporting aspects of Novotech's operations.

    Minimum Qualifications & Experience:

    • Registered nurse, pharmacist, or holder of a health/biomedical or related scientific degree/qualification.
    • Minimum of 2 years of safety-related experience in a pharmaceutical company or CRO environment.
    • At least 2 years in a Drug Safety Associate role at Novotech.
    • Expertise in international drug safety regulatory reporting, case processing, client communication, and data reconciliation.
    • Strong understanding of medical terminology and ability to write clear, concise medical text.
    • Proficiency in different disease and therapeutic areas is a plus.
    • Fluency in English and the ability to evaluate data, follow guidelines, and work with SOPs.

    Key Responsibilities:

    • Manage drug safety reporting for Novotech's business, ensuring compliance with regulatory requirements.
    • Configure and review safety databases with study-specific information.
    • Prepare and review study-specific safety management plans and related tools per client requirements, SOPs, and guidelines.
    • Process cases by completing full case information on the database, conducting quality reviews for accuracy, triaging cases for workflow prioritization, and ensuring timely narrative writing, coding, approval, and reconciliation of safety data.
    • Liaise with medical monitors, drug safety physicians, clients, and study teams to clarify necessary case processing information.
    • Prioritize data entry based on the date of receipt, ensuring adherence to SOPs and guidelines.
    • Process adverse event reports, maintain the safety database, track systems, and prepare reports for regulatory authorities.
    • Ensure timely submission of reports to regulatory agencies and respond to inquiries promptly, maintaining detailed tracking of submissions for compliance.
    • Participate in assigned projects, including audit readiness activities and interviews for inspections.
    • Collaborate with local and global project teams, ensuring timely delivery of responsibilities.
    • Communicate proactively regarding issues in the pharmacovigilance process.
    • Conduct literature searches to monitor adverse event reports and post-approval commitments.
    • Continuously develop personal skills through project finance, technical training, and mentoring others.
    • Maintain compliance with company guidelines and HR policies.
    • Perform other related duties as assigned.
    • Provide oversight and mentorship to junior staff on project management.
    • Maintain expertise in monitoring regulatory requirements for expedited ICSRs and periodic reports (DSUR/PSUR/PBRER).
    • Lead the updating of the country reference manual.
    • Act as a subject matter expert in pharmacovigilance.

    About Novotech: Novotech is a leading Asia-Pacific biotech-specialist CRO offering clinical development services across all trial phases and therapeutic areas. With ISO 27001 and ISO 9001 certifications, Novotech delivers high standards in IT security and clinical quality. The company operates in 11 geographies with key medical institution partnerships, supporting over 3,700 clinical projects globally.

    Join the Team: As part of a dynamic team at Novotech, you will contribute to cutting-edge clinical research. With over 2,750 employees across Asia-Pacific, the U.S., and the UK, Novotech is positioned to drive global clinical trials for biopharmaceutical clients.

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