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    Senior Medical Director, Global Patient Safety

    Astrazeneca
    5-7 years
    Not Disclosed
    Dublin
    10 July 24, 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, 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 Title: Senior Medical Director, Global Patient Safety

    Location: Dublin, Leinster, Ireland
    Job ID: R-193377
    Date Posted: 11/06/2024

    Company Overview:

    At Alexion AstraZeneca Rare Disease, we are committed to making a difference in the lives of individuals affected by rare and devastating diseases. Our mission is guided by the belief that every patient deserves innovative and effective treatments. We celebrate the diversity and unique perspectives of our team, knowing that these differences drive our ability to create breakthroughs and deliver exceptional value to patients and their families.

    Role Overview:

    As the Senior Medical Director, you will oversee global safety surveillance and risk management for Alexion’s therapeutic areas. Your role involves defining and executing strategies for safety and risk management, leading a team of Medical Directors and Safety Scientists. You will ensure comprehensive risk assessment and management throughout the product lifecycle, from development to market.

    Key Responsibilities:

    Safety Surveillance and Risk Management:

    • Lead and manage global safety surveillance, benefit-risk assessments, and risk management for assigned Alexion product portfolios throughout their lifecycle.
    • Guide a team of Medical Directors and Safety Scientists in identifying, evaluating, and resolving safety signals, and communicating risk management plans.
    • Provide expert medical and pharmacovigilance guidance to inform decision-making based on complex data, including risk/benefit evaluations and pharmacoepidemiological studies.
    • Partner with internal stakeholders and external affiliates to deliver integrated pharmacovigilance and risk management support.
    • Lead Product Safety Management Teams to support decision-making, drive evidence-based conclusions, and develop critical next steps.
    • Oversee the monitoring and communication of new safety issues, ensuring timely and accurate reporting and documentation according to international standards.

    Regulatory and Documentation Responsibilities:

    • Ensure timely generation of aggregate reports, regulatory responses, and risk management documents by the team.
    • Define and implement risk minimization activities for assigned product portfolios.

    Requirements:

    Essential:

    • MD or equivalent medical degree, or a degree in life sciences, pharmacy, or nursing with relevant Patient Safety and/or Clinical/Drug Development experience.
    • 5-7 years of experience in safety and risk management within the pharmaceutical, biotech, or CRO industry.
    • Strong problem-solving skills with the ability to develop innovative solutions for complex problems.
    • Experience managing multiple complex tasks and projects simultaneously, including oversight of others.
    • Knowledge of global safety regulations, including US and EU pre- and post-marketing requirements.
    • Proficiency in Microsoft Word, PowerPoint, and Excel.

    Preferred:

    • Experience with rare, ultra-rare, or orphan disease areas.
    • Exceptional verbal and written communication skills, including the ability to influence management and senior leaders.
    • Demonstrated independent judgment based on extensive knowledge and expertise.
    • Strong personal time-management and project-management skills.

    Work Environment:

    This role is primarily office-based, requiring the ability to use a computer, engage in communication via phone, video, and electronic messaging, and collaborate effectively with others. The role requires a commitment to in-office work at least three days per week, with flexibility to accommodate individual needs.

    Why Join Us?

    At AstraZeneca, we believe that diverse teams drive innovative solutions and better outcomes. We are committed to fostering an inclusive environment where every employee is valued. We welcome applications from all qualified candidates and are dedicated to complying with all applicable laws and regulations regarding non-discrimination and employment eligibility.

    Apply today to be part of a team that is dedicated to advancing science and improving patient lives!

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