Senior Drug Safety - Pune - Thepharmadaily

    Thepharmadaily
    Thepharmadaily Pune

    3 days ago

    Full time
    Description

    Key Responsibilities

    Case Management and Reporting

    • Support the Pharmacovigilance team in collecting, tracking, and processing Adverse Events (AEs) from all sources with accuracy and efficiency.
    • Independently triage AEs to determine reportability in compliance with regulatory guidelines and clinical assessment standards.
    • Code AEs using MedDRA and WHODRUG, applying clinical judgment to ensure correct categorization.
    • Conduct quality control checks on case data to ensure accuracy, consistency, and completeness in safety databases and regulatory reporting forms (e.g., MedWatch, CIOMS I).

    Regulatory Compliance and Documentation

    • Ensure timely submission of expedited case reports to regulatory authorities in compliance with global regulations.
    • Draft concise and clinically sound AE narratives following established guidelines.
    • Formulate and communicate follow-up queries to clients or stakeholders for additional case information.
    • Assist in the preparation of aggregate reports and regulatory documentation as required.

    Collaboration and Leadership

    • Work collaboratively with PV management, project managers, and internal teams to meet deadlines and project goals.
    • Lead and mentor junior staff, including Drug Safety Associates and Drug Safety Coordinators, in case processing.
    • Participate in the regular reconciliation of Serious Adverse Events (SAEs) between drug safety and clinical trial databases.

    Continuous Improvement and Development

    • Gain deep knowledge of client products and therapeutic areas.
    • Contribute to the creation and maintenance of SOPs, work instructions, and other pharmacovigilance documentation.
    • Stay current with evolving drug safety regulations and contribute to ongoing process improvements within the team.

    Qualifications

    Education

    • Bachelor's degree in a life sciences discipline (e.g., Pharmacy, Nursing) is preferred.

    Experience

    • Minimum of 5 years of experience in pharmacovigilance, including at least 3 years in drug safety.
    • Broad knowledge of domestic and international regulations, including ICH and FDA guidelines.
    • Strong understanding of the drug development process and AE reporting requirements.

    Skills

    • Proficient in MedDRA and WHODRUG coding.
    • Familiar with FDA and international AE reporting regulations.
    • High attention to detail and ability to manage complex data accurately.
    • Excellent written and verbal communication skills, especially in crafting clear narratives.
    • Strong time management and multitasking abilities.
    • Proficiency in Microsoft Office and safety database software.

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