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    Senior Medical Director, Global Drug Safety

    Astrazeneca
    5+ years
    Not Disclosed
    Boston
    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

    Position: Senior Medical Director, Safety Surveillance and Risk Management

    Location: [City, State/Region, Country]
    Company: Alexion, AstraZeneca Rare Disease

    Position Overview:

    As the Senior Medical Director, you will provide strategic and operational leadership for Alexion’s Safety Surveillance and Risk Management activities across a designated therapeutic area. Your role is global in scope, guiding a team of Medical Directors and Safety Scientists responsible for the entire lifecycle of the product portfolio, from pre-approval to post-market surveillance. You will leverage your medical and drug safety expertise to make critical decisions based on complex risk/benefit evaluations, interpreting pharmacoepidemiological and clinical trial data, and implementing risk mitigation strategies. You may also represent the Global Patient Safety department as a subject matter expert on various internal strategic or advisory committees. Reporting to the Executive Medical Director, Global Patient Safety, your influence extends across functional goals, collaborating with Clinical & Medical and Commercial organizations to optimize product safety and regulatory success.

    Key Responsibilities:

    • Lead and provide oversight for ongoing safety surveillance, benefit-risk assessments, and risk management activities for Alexion's product portfolio throughout its lifecycle.
    • Direct a team of Medical Directors and Safety Scientists in identifying, evaluating, and resolving safety signals, and effectively communicating risk management plans.
    • Provide medical and pharmacovigilance expertise for complex risk/benefit evaluations, data interpretation, and risk mitigation.
    • Partner with internal leaders within Global Patient Safety and other Alexion functions and affiliates to deliver integrated pharmacovigilance and risk management support.
    • Lead Product Safety Management Teams, support key decision-making, and develop pivotal next steps.
    • Oversee work on products or issues with high patient safety or regulatory scrutiny.
    • Ensure continuous safety surveillance, prompt detection, and communication of new safety issues.
    • Ensure timely generation of aggregate reports, regulatory responses, and risk management documentation.
    • Define and implement risk minimization activities for the assigned product portfolio.

    Required Qualifications:

    • MD or equivalent degree, or a degree in life sciences, pharmacy, or nursing with demonstrated experience in Patient Safety and/or Clinical/Drug Development.
    • Strong problem-solving skills with the ability to develop innovative solutions to complex issues.
    • Ability to manage multiple overlapping tasks and projects, including oversight of team members.
    • Deep understanding of GPS deliverables, standards, and processes.
    • Comprehensive knowledge of US and EU safety regulations pre- and post-marketing.
    • Proficiency in using a computer, engaging in communications via phone, video, and electronic messaging, and collaborating with others.

    Preferred Qualifications:

    • 5-7 years of relevant experience in safety and risk management within the pharmaceutical, biotech, or CRO industry.
    • Experience in rare, ultra-rare, or orphan disease areas.
    • Strong verbal and written communication skills, including the ability to influence management and senior leaders.
    • Excellent independent judgment and expertise.
    • Strong personal time-management and project-management skills.
    • Proficiency in Microsoft Word, PowerPoint, and Excel.
    • Availability for in-office work three days a week, supporting collaboration and innovation.

    Why Join Us?

    At Alexion, we embrace diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds and perspectives, harnessing industry-leading skills. We believe that diversity enhances our work. We welcome applications from all qualified candidates and comply with all applicable laws and regulations regarding non-discrimination in employment, recruitment, work authorization, and employment eligibility verification.

    Ready to make a greater impact? Apply now and be a part of our unique and ambitious world!

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