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    Senior Medical Director - Pharmacovigilance/Drug Safety

    Parexel
    2+ years
    Not Disclosed
    Remote, USA
    10 Oct. 30, 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

    Company Overview:

    At Parexel, we are dedicated to improving global health by providing comprehensive biopharmaceutical services that enable clients to transform scientific discoveries into innovative treatments. Our core values—Patients First, Quality, Respect, Empowerment, and Accountability—guide everything we do.

    Job Purpose:

    The Senior Medical Director plays a pivotal role in leading the Safety Medical Sciences business functions within the EMEA region. This newly created position requires a seasoned professional with extensive experience in Pharmacovigilance/Drug Safety, team management, and a desire to advance into a larger leadership role.

    Key Responsibilities:

    • Leadership and Strategy: Provide direction to the Safety Medical Sciences functions and contribute strategic insights to Safety Services Leadership.
    • Technology Implementation: Oversee the adoption of suitable technologies and innovations, acting as Business Owner for related systems and Process Owner for applicable SOPs.
    • Representation: Act as the representative for the department at various internal and external forums, contributing to thought leadership initiatives.
    • Resource Management: Ensure effective resource allocation, maintain overall quality, and drive business continuity, utilization, and profitability.

    Key Accountabilities:

    • Maintain in-depth knowledge of the adverse event/safety profiles of assigned products, including regulatory guidelines and client procedures.
    • Organize workloads to ensure compliance with global regulatory requirements and internal timelines for adverse event reporting.
    • Attend and present at client and cross-functional meetings as a Subject Matter Expert (SME).
    • Oversee the quality of function outputs and ensure Key Performance Indicators (KPIs) are met.
    • Collaborate with the Safety Services Leadership Team to provide strategic and competitive inputs.

    Medical Review Responsibilities:

    • Conduct medical reviews of cases, including non-serious and serious adverse events, following client and Parexel SOPs.
    • Write and assess Pharmacovigilance/Marketing Authorization Holder (MAH) comments and causality assessments.
    • Review and author aggregate reports, ensuring medical content consistency and compliance with SOPs.
    • Review and sign off on adverse event reports for accuracy, clinical importance, and relevance to study drugs.

    Signal Detection and Risk Management:

    • Perform signal detection activities in alignment with client conventions and timelines.
    • Author and review Safety Evaluation Reports (SERs) and responses to health authority requests.
    • Contribute to Pharmacovigilance and Risk Management planning, including safety surveillance strategy preparation.

    Additional Responsibilities:

    • Review safety sections of clinical protocols and regulatory submissions, ensuring alignment with safety strategies.
    • Manage a team of Safety Officers and other personnel, ensuring compliance and quality in deliverables.
    • Continuously evaluate safety and benefit-risk assessment strategies for assigned therapeutic areas.

    Knowledge and Experience:

    • Extensive experience in drug safety and clinical trials, along with clinical practice experience.
    • Proven managerial and leadership experience, with a strong understanding of medical terminology.

    Education:

    • Doctor of Medicine (MD) or equivalent medical qualification from a recognized institution.
    • Completion of a basic training program in clinical medicine (residency, internship, etc.).

    #LI-REMOTE

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