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    Drug Safety Associate Ii

    Parexel
    2+ years
    Not Disclosed
    Mohali
    10 Sept. 7, 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

    Drug Safety Support Specialist

    Responsibilities:

    • Assist in developing project-specific safety procedures, workflows, and templates.
    • Support the setup of project-specific safety databases, including developing data entry guidelines and conducting user acceptance testing.
    • Triage incoming safety reports for completeness, legibility, and validity.
    • Ensure electronic documentation and quality control of drug safety information.
    • Enter case reports into safety databases and tracking systems.
    • Manage follow-ups and queries, including coding data and writing case narratives.
    • Create and maintain project-specific working files, case report files, and central project files.
    • Assist with additional Drug Safety Specialist and Safety Service Project Leader (SSPL) tasks as needed.
    • Inform Line Manager, Safety Services Project Leader (SSPL), or Project Leader (PL) and Regional Head of PV Operations about potential project scope changes.
    • Support Medical Directors/Safety Physicians with medical monitoring activities as required.
    • Participate in client and investigator meetings and attend internal drug safety and project-specific training sessions.
    • Conduct literature searches and prepare for, participate in, and follow up on audits and inspections.
    • Delegate tasks to Drug Safety Assistants as appropriate.
    • Assist in developing expedited reporting procedures and with electronic reporting registration on behalf of sponsors.
    • Help set up and deploy worldwide reporting to regulatory authorities, CECs, local ECs, and investigator sites, both electronically and in hard copy.
    • Submit safety reports to investigators via ISIS (International Safety Information System).
    • Measure investigative site performance in conducting required tasks in ISIS and track and file submission cases as needed.
    • Assist with unblinding of SUSARs and support the collection and review of metrics for reporting compliance.

    Skills:

    • Strong analytical and problem-solving abilities.
    • Proficient in database and literature searches.
    • Excellent interpersonal, verbal, and written communication skills.
    • Highly organized with strong prioritization skills.
    • Collaborative team player with a client-focused approach.
    • Proficient in computer applications, including Microsoft Excel and PowerPoint.

    Knowledge and Experience:

    • Related experience in a healthcare environment is advantageous.
    • Minimum of a Bachelor’s Degree in a relevant discipline (e.g., Science, Medical) with 3 years of pharmaceutical industry experience, or 2 years of pharmacovigilance experience.
    • Experience in quality, compliance, or case processing roles is highly desirable.
    • Understanding of GxP requirements and global pharmacovigilance preferred.
    • Ability to function effectively in a global matrix environment.
    • Excellent communication and writing skills with the ability to manage and resolve issues independently.

    Education:

    • Bachelor’s Degree in a relevant field (e.g., Science, Medical) with 3 years of pharmaceutical industry experience, or 2 years of pharmacovigilance experience.

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