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    Associate Director, Senior Patient Safety Scientist

    Astrazeneca
    11+ years
    Not Disclosed
    Remote, USA
    10 Dec. 17, 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, 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 Title: Associate Director, Senior Patient Safety Scientist
    Location: [Location]
    Job ID: R-215392
    Date Posted: 12/16/2024

    Introduction to the Role:
    Are you ready to lead the charge in ensuring patient safety and making a real difference? As the Associate Director, Senior Patient Safety Scientist, you will take the lead in reviewing safety data and related documents to identify potential safety issues. Working closely with the Global Safety Physician (GSP) and Patient Safety Scientist, you will play a critical role in authoring safety documents, preparing regulatory reports, and presenting safety data and analyses. Join us in delivering life-changing medicines to patients worldwide.

    Key Responsibilities:

    • Lead Pharmacovigilance and Risk Management: Spearhead proactive pharmacovigilance and risk management planning for complex products, including preparation of safety aspects of Global Risk Management Plans (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) in collaboration with the GSP and relevant stakeholders.
    • Project Team Leadership: Lead Patient Safety (PS) activities for cross-functional project teams working on marketed products and/or developmental compounds.
    • Provide Safety Expertise: Offer expert safety insights for Investigator Brochures, Protocols, Informed Consents, and Clinical Study Reports.
    • Safety Strategy Management: Serve as the Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.
    • Safety Information Review: Present complex safety issues to the Safety Information Review Committee (SIRC) and lead the data evaluation and discussion of results with the SIRC Chair, GSP, and key stakeholders.
    • Safety Information Collaboration: Collaborate with the GSP and Clinical representatives to author the Reference Safety Information (RSI) for complex marketed and development products.
    • Regulatory Document Leadership: Author or provide strategic input for periodic regulatory documents such as PBRERs, PSURs, DSURs, ensuring compliance with agreed processes and timelines.
    • Contract Negotiations: Participate in negotiations and offer expertise in the PS components of contracts/agreements with third parties to ensure quality and integrity.
    • Training and Mentorship: Mentor and train junior team members in pharmacovigilance processes, analytical methodologies, and patient safety best practices.
    • Regulatory Submissions Leadership: Lead or contribute to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in collaboration with the GSP and other experts.

    Essential Skills and Experience:

    • Degree in biosciences or an equivalent healthcare/pharmaceutical background, with proven competency in patient safety and clinical development.
    • In-depth understanding of Patient Safety regulatory obligations and related policies, processes, and procedures.
    • Awareness of medico-legal aspects related to patient safety.
    • 11 to 13 years of experience in Pharmacovigilance and Patient Safety, with a total of 14 to 16 years of experience in relevant fields.

    Desirable Skills and Experience:

    • Well-developed interpersonal skills and cultural sensitivity.
    • Strong ability to network across functions globally.

    Why AstraZeneca?
    At AstraZeneca, we are reimagining how we work by driving efficiency on a global scale. Our entrepreneurial approach challenges the status quo, embracing risk to transform processes through simplification, automation, and data analytics. Join us in our mission to make a difference for patients worldwide.

    We believe in a diverse and inclusive work environment where all backgrounds and perspectives are valued. We invite applications from qualified candidates, ensuring equal opportunity in employment.

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