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    Senior Medical Director - Pharmacovigilance/Drug Safety

    Parexel
    7+ years
    Not Disclosed
    Remote, USA
    10 Sept. 26, 2024
    Job Description
    Job Type: Remote 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

    Job Opportunity: Senior Medical Director

    About This Role:

    At Parexel, we are dedicated to improving global health by offering a comprehensive suite of biopharmaceutical services that assist clients in transforming scientific discoveries into effective treatments. We believe in our core values: Patients First, Quality, Respect, Empowerment, and Accountability.

    We are seeking a Senior Medical Director with extensive experience in pharmacovigilance and drug safety. This newly created role for the EMEA region requires prior team management experience and the potential to grow into a larger leadership position.

    Job Purpose:

    The Senior Medical Director will provide leadership and direction to the Safety Medical Sciences business functions and other assigned areas, as well as offer strategic insights to Safety Services Leadership. You will be responsible for implementing suitable technology and innovations for the function, acting as the Business Owner for related systems and the Process Owner for applicable SOPs.

    Key Responsibilities:

    • Maintain a comprehensive understanding of the adverse event and safety profiles of assigned products, including labeling documents, data handling conventions, client guidelines, and global drug safety regulations.
    • Stay informed of global regulatory requirements and reporting obligations, organizing workloads to ensure compliance with internal and regulatory timelines for adverse event reporting.
    • Attend and present at client and cross-functional meetings, serving as a Subject Matter Expert (SME).
    • Ensure quality standards are met and oversee the function’s Key Performance Indicators (KPIs).
    • Collaborate with the Safety Services Leadership Team to provide strategic and competitive inputs for the department and organization.
    • Perform medical reviews of cases, including spontaneous and clinical trial reports, and liaise with clients as needed.
    • Author and assess pharmacovigilance comments and company causality assessments.
    • Review adverse events for accuracy, clinical relevance, and relationship to the study drug, ensuring compliance with SOPs.
    • Author and review aggregate reports for medical content consistency according to client requirements.
    • Conduct signal detection activities, including medical assessments of safety alerts obtained from data mining.
    • Prepare and review periodic safety reports (PBRER/PSUR, DSUR, etc.) in line with regulatory requirements.
    • Support regulatory agency submissions by reviewing safety data and preparing relevant sections of submission documents.
    • Oversee and mentor a team of safety officers and other pharmacovigilance personnel.
    • Ensure alignment of therapeutic area objectives and safety strategies while managing compliance and quality.

    Knowledge and Experience:

    • Extensive knowledge and experience in drug safety and clinical trials.
    • Clinical practice experience is essential.
    • Proven managerial and leadership experience.
    • Strong understanding of medical terminology.

    Education:

    • Doctor of Medicine (MD) or medically qualified from a recognized medical school.
    • Completion of basic clinical medicine training (residency, internship, etc.) is required.

    If you're ready to lead in pharmacovigilance and contribute to our mission of improving global health, we invite you to apply!

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