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    Executive Director, Drug Safety

    Organon
    7+ years
    Not Disclosed
    Philadelphia
    10 Oct. 16, 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: Senior Director, Safety Science

    Slug: senior-director-safety-science-organon

    Job Description

    The Position

    This strategic leadership role is accountable for setting and implementing the overall safety strategy and procedures for an assigned therapeutic area product portfolio, including both medicinal products and medical devices. The focus is on post-marketing pharmacovigilance (PV) activities from a scientific perspective, ensuring patient safety is safeguarded.

    Key Responsibilities:

    • Lead interactions regarding product safety issues with Organon governance committees and regulatory agencies, actively participating in various safety-related decision-making bodies.
    • Build strong relationships with cross-functional teams to ensure alignment of development, regulatory, and medical strategies with safety objectives.
    • Drive scientific safety assessments and guide Drug Safety Leads and Safety Scientists in effective benefit-risk decision-making.
    • Oversee core safety science processes and facilitate PV system implementation and issue resolution.
    • Manage, develop, and mentor staff within the Safety Science Therapeutic Areas at the Global Pharmacovigilance and Safety Science (GPSS) Department.

    Organizational Relationships

    • Reports to the Associate Vice President, Safety Science Lead, GPSS.

    Responsibilities Include:

    • Leading and driving safety strategy for assigned products.
    • Ensuring the scientific foundation of the Benefit-Risk profile and compliance with drug safety regulations.
    • Fulfilling leadership roles in Benefit-Risk Balance decision-making committees.
    • Collaborating with internal departments to align on global risk management strategies.
    • Authoring high-quality aggregate safety reports and ensuring proper scientific reflection of the B/R balance in safety updates.

    Health Authority Interaction:

    • Represent GPSS in Health Authority meetings and act as a key subject matter expert during inspections.
    • Manage interactions with safety-related vendors and oversee their activities.

    Required Education, Experience, and Skills:

    • Medical Degree with clinical experience, ideally in women's health or related fields.
    • 10+ years of experience in the pharmaceutical industry, with 5-10 years in drug safety and pharmacovigilance.
    • Extensive knowledge of PV deliverables, standards, and global regulations.
    • Strong communication, analytical, and leadership skills, with the ability to build effective relationships.

    Who We Are:

    Organon delivers ingenious health solutions that enable people to live their best lives. As a $6.5 billion global healthcare company, we focus on making a difference for women, their families, and communities. Our vision is a better and healthier every day for every woman.

    Equal Opportunity Employer:

    We welcome applications from diverse backgrounds and are committed to creating an inclusive environment for all applicants.

    Search Firm Representatives:

    Organon LLC does not accept unsolicited assistance from search firms for employment opportunities.

    Salary Information:

    Applicable salary ranges are provided below and may vary by location.

    • Annualized Salary Range (US)
    • Annualized Salary Range (Global)
    • Annualized Salary Range (Canada)

    Employee Status: Regular
    Relocation: No relocation
    VISA Sponsorship: Not available
    Travel Requirements: Must satisfy all applicable travel and credentialing requirements, including vaccination prerequisites.

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