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    Associate Medical Safety Director

    Iqvia
    5+ years
    Not Disclosed
    Remote - Europe
    10 Sept. 5, 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: Associate Medical Safety Director

    Location: Office-based, Hybrid, or Home-based in South Africa

    Company: IQVIA

    About IQVIA:

    IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We excel at creating intelligent connections to accelerate the development and commercialization of innovative medical treatments, aiming to improve patient outcomes and population health worldwide.

    Role Overview:

    We are seeking an Associate Medical Safety Director to provide expert medical, scientific, and therapeutic knowledge in pharmacovigilance services. This role encompasses a broad range of responsibilities related to medical safety, including maintaining and providing pharmacovigilance and risk management expertise to both internal and external stakeholders.

    Key Responsibilities:

    • Conduct aggregate reviews of safety information, including clinical data, to maintain a comprehensive understanding of a product’s safety profile.
    • Lead signal detection and analysis, including developing signal detection strategies, reviewing Signal Detection Reports, and raising potential signals for team discussion.
    • Contribute to safety analysis reports and present signal evaluation data as needed.
    • Provide medical review and contribute to key regulatory reports such as IND Annual Reports, EU Periodic Benefit-Risk Evaluation Reports, and US Periodic Reports.
    • Review and contribute to Development Risk Management Plans, EU Risk Management Plans, or US Risk Evaluation and Mitigation Strategies.
    • Oversee and contribute to benefit-risk evaluations for drugs in clinical trials and post-marketing settings.
    • Support label development, review, and updates with medical safety contributions.
    • Assist in preparing the Integrated Safety Summary or Common Technical Document.
    • Perform medical review of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs), including narrative content, queries, coding, and causality assessments.
    • Represent safety and clinical data review findings in internal and external meetings.
    • Provide medical safety support at Safety Governance and other relevant meetings.

    Qualifications and Skills:

    • A medical degree from an accredited and internationally recognized medical school.
    • Approximately three years of clinical practice experience, with at least two additional years in the pharmaceutical industry or a related field, or an equivalent combination of education and experience.
    • Knowledge of federal and local regulations and guidelines pertaining to clinical research, safety, good clinical practice, and pharmaceutical research processes.
    • Expertise in signal detection, aggregate reports, and risk management.
    • Ability to synthesize and critically analyze data from multiple sources, and communicate complex clinical issues effectively in both oral and written forms.
    • Proven ability to prioritize and meet deadlines, manage multiple assignments, and adapt to changing business needs.
    • Strong interpersonal skills with the ability to establish and maintain effective working relationships with coworkers, managers, and clients, including providing mentorship if required.

    Why Join Us?

    At IQVIA, we are committed to driving innovation and improving patient outcomes. We offer a supportive and dynamic work environment where you can make a significant impact. Whether you choose to work in the office, hybrid, or remotely, we provide the flexibility and resources you need to excel in your role.

    Interested in Learning More?

    To find out more about this role and explore other opportunities at IQVIA, visit our careers page: IQVIA Careers.

    IQVIA is an equal opportunity employer. We are dedicated to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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