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    Medical Director, Global Patient Safety

    Astrazeneca
    4+ years
    Not Disclosed
    Barcelona
    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: Medical Director, Global Patient Safety

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

    Position Overview:

    As the Medical Director for Global Patient Safety, you will be responsible for executing safety and risk management activities for one or more clinical development projects or marketed products. Your role is crucial in ensuring the safe and effective use of Alexion’s products by patients and healthcare providers. Leveraging your clinical and pharmacovigilance expertise, you will identify and evaluate safety signals, make informed decisions on risk/benefit evaluations, and interpret pharmacoepidemiological or clinical trial data. This position, reporting to the Senior Medical Director, Risk Management Pharmacovigilance, is an individual contributor role within the organization.

    Key Responsibilities:

    • Lead risk management evaluations and resolutions for assigned products and projects.
    • Identify and analyze potential safety signals through data review and research for monthly Safety, Risk Management, and Safety Science Management Team meetings.
    • Direct the Safety Management Team, ensuring a safety and risk/benefit-driven agenda from inception to resolution.
    • Represent Global Patient Safety (GPV) on project/product teams, ensuring compliance with internal and external standards for adverse event processing, risk mitigation, and other safety-related processes.
    • Collaborate with external resources like Clinical Operations and Clinical Scientists to identify and resolve potential safety signals.
    • Manage pre- and post-approval safety signals, ensuring timely detection, validation, and resolution.
    • Ensure timely and accurate documentation of risk management actions and decisions, project-managing GPV deliverables to meet applicable standards.
    • Conduct medical assessments of causality for Individual Case Safety Reports (ICSRs), identify process improvement opportunities, and implement changes.
    • Evaluate aggregate safety data and contribute to Periodic Safety Update Reports, Risk Management Plans, and other regulatory and internal safety documents.
    • Provide medical interpretation of complex pharmacovigilance and pharmacoepidemiological data to support clinical and regulatory decision-making.
    • Manage updates to product information, labeling, and other documentation as necessary.
    • Evaluate issues arising from PV Operations, such as the use of MedDRA dictionary and IME lists.
    • Provide medical input for ARGUS search criteria and develop appropriate searches where no SMQ exists.

    Required Qualifications:

    • MD or equivalent required.
    • At least five years of relevant safety and risk management experience in the pharmaceutical industry.
    • Comprehensive knowledge of pharmacovigilance deliverables, standards, and processes.
    • In-depth understanding of drug-induced diseases related to the assigned therapeutic/product area(s).
    • Excellent independent judgment based on advanced knowledge and expertise.
    • Strong verbal and written communication skills, with the ability to recommend courses of action that impact department or line decisions.
    • Effective problem-solving skills, with the ability to develop multiple solutions to complex issues.
    • Ability to manage multiple overlapping complex tasks, including oversight of others, to meet project deadlines.

    Preferred Qualifications:

    • Over four years of clinical medicine experience (post-training/residency).
    • Experience in rare, ultra-rare, or orphan disease areas.
    • Strong personal time-management and project-management skills.
    • Ability to collaborate and partner with internal and external teams, ensuring consistency with overall development and commercial strategies.

    Why Join Us?

    Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team, representing a wide range of perspectives and harnessing industry-leading skills. We believe that a more inclusive environment 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 difference? Apply now and be a part of our transformative journey!

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