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    Medical Director, Patient Safety Physician

    Astrazeneca
    10+ years
    Not Disclosed
    Boston
    10 July 24, 2024
    Job Description
    Job Type: Full Time Education: MD, MBBS 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: Medical Director, Patient Safety Physician

    Career Level: F
    Location: [City, State/Region, Country]
    Company: AstraZeneca

    Role Overview:

    As the Medical Director, Patient Safety Physician, you will be responsible for developing and executing the clinical safety strategy for AstraZeneca’s drug projects and products. This role encompasses all stages of drug development, including market presence. Your primary focus will be on implementing and communicating safety strategies, evaluating adverse events, managing risk, and ensuring compliance with global regulatory requirements. You will report to the Senior Medical Director and work collaboratively with cross-functional teams to ensure the safety and efficacy of our products.

    Key Responsibilities:

    Safety Governance and Risk Management:

    • Develop and implement the clinical safety strategy for assigned AstraZeneca drug projects and products throughout their lifecycle, including late-stage development and post-marketing phases.
    • Define and communicate identified and potential risks, propose mitigation strategies, and establish safety criteria for clinical programs.
    • Review and endorse Patient Risk Management Plans (PRMP) and provide expertise for pharmacovigilance plans and risk minimization activities.
    • Represent Patient Safety (PS) on cross-functional Clinical and Project Teams for developmental and marketed products.
    • Provide strategic input into clinical development planning and review safety-related project requirements and documents.

    Signal Detection, Evaluation, and Labelling:

    • Oversee safety surveillance activities, including medical review of individual safety cases, signal detection, and evaluation.
    • Provide medical input for regulatory documents and labeling updates, utilizing appropriate information sources and database searches.
    • Collaborate with external providers and discuss data evaluation results with key stakeholders.
    • Prepare and manage safety information documents, including Developmental Core Safety Information (DCSI) and responses to regulatory requests.

    Regulatory Reports and Submissions:

    • Review and provide medical input for periodic safety reports (e.g., PBRERs, PSURs, DSURs) and regulatory submissions (e.g., NDA, BLA, MAA).
    • Contribute to safety agreements and licensing agreements, and support due diligence activities as needed.

    Other Activities:

    • Participate in and lead process improvement initiatives and contribute to advancements in methodology and processes.
    • Mentor and train junior team members in signal evaluation, risk management, and safety report preparation.
    • Ensure personal readiness for internal audits and regulatory inspections, and collaborate effectively with cross-functional and external teams.

    Required Qualifications:

    • Medical degree (e.g., MD, MBBS).
    • At least 2 years of clinical experience post-registration preferred.
    • Minimum of 11-13 years of experience in patient safety, with clear evidence of successful delivery.
    • Extensive knowledge of the pharmaceutical/biopharmaceutical industry, particularly in clinical research, safety reporting, and risk management.

    Skills and Capabilities:

    Leadership:

    • Strong commitment to customer service and integrity.
    • Strategic leadership with the ability to identify opportunities and drive accountability.
    • Effective collaboration and development of people and organizations.

    Technical Expertise:

    • In-depth understanding of drug development and disease areas.
    • Expertise in pharmacovigilance and patient benefit-risk assessment.
    • Integrative thinking and excellence in safety evaluation.

    Core Competencies:

    • Conceptual thinking and influencing skills.
    • Initiative and innovation in improving practices and business relationships.
    • Strong business relationship management and negotiation skills.

    Why Join Us?

    AstraZeneca is committed to building a diverse and inclusive team that represents a wide range of perspectives and skills. We believe that diversity enhances our work and drives innovation. We welcome applications from all qualified candidates and comply with all applicable laws and regulations regarding non-discrimination, work authorization, and employment eligibility verification.

    Apply today to be part of our mission to advance science and improve patient outcomes!

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