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    Associate Medical Safety Director

    Iqvia
    7+ years
    Not Disclosed
    Belgrade
    10 Sept. 19, 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

    Associate Medical Safety Director

    Join Our Expanding Lifecycle Safety Medical Team!

    We are seeking Associate Medical Safety Directors to join our growing team in Portugal, Hungary, Slovakia, Romania, Bulgaria, Serbia, and Croatia. This role involves participating in all facets of Medical Safety activities as outlined in our scope of work. Key responsibilities include providing pharmacovigilance (PV) and risk management expertise to internal and external stakeholders, conducting medical evaluations of post-marketing adverse drug reactions (ADRs), contributing to signal management and benefit-risk evaluations for drugs in clinical trials and post-marketing settings, and preparing responses to health authority inquiries.

    Role Responsibilities

    • Aggregate Safety Reviews: Conduct comprehensive reviews of safety information, including clinical data, to maintain oversight of a product's safety profile.
    • Signal Detection: Lead signal detection and analysis, developing strategies for detection frequency and timing, reviewing Signal Detection Reports, and raising potential signals for team discussion.
    • Medical Review: Provide medical reviews and contributions to IND Annual Reports, EU Periodic Benefit-Risk Evaluation Reports, and US Periodic Reports.
    • Risk Management Plans: Contribute to the development of Risk Management Plans and evaluate benefit-risk profiles for drugs in clinical trials and post-marketing.
    • Label Development: Provide safety oversight for label development, reviews, and updates.
    • Integrated Safety Summary: Contribute to the Integrated Safety Summary or Common Technical Document.
    • Adverse Event Review: Perform medical reviews and clarify trial-related AEs and post-marketing ADRs, including narrative content and coding.
    • Stakeholder Representation: Present safety and clinical data findings during internal and external meetings.
    • Safety Governance Support: Attend and contribute to Safety Governance meetings as needed.

    Qualifications

    • Medical Degree: A medical degree from an accredited and internationally recognized institution.
    • Experience: Approximately three years of clinical practice experience, plus two additional years in the pharmaceutical industry or a related field, or an equivalent combination of education and experience.
    • Regulatory Knowledge: Understanding of federal and local regulations related to clinical research, safety, and good clinical practice.
    • Product Knowledge: Maintain knowledge of assigned product portfolios, therapeutic areas, and recent literature.
    • Signal Detection Expertise: Experience with signal detection, aggregate reporting, and risk management.
    • Analytical Skills: Ability to synthesize and critically analyze data from various sources and communicate complex clinical issues effectively.
    • Organizational Skills: Proven ability to set and meet priorities, deadlines, and objectives while working under pressure.
    • Relationship Building: Capacity to establish and maintain effective working relationships with colleagues, managers, and clients, with potential for mentorship.

    About IQVIA

    IQVIA is a leading global provider of clinical research services and healthcare intelligence. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.

    To learn more about us and apply, visit IQVIA Careers.

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