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    Director, Medical Safety Science

    Ascendis Pharma
    8+ years
    $225,000 - $245,000 per year
    Palo Alto
    10 Oct. 2, 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: Medical Safety Science Director

    Company Overview
    Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. We are advancing innovative programs in Endocrinology, Rare Diseases, and Oncology. Guided by our core values of Patients, Science, and Passion, we leverage our TransCon® drug development platform to fulfill our mission of creating potentially best-in-class therapies for unmet medical needs. Our culture promotes an environment where skilled, adaptable professionals can make a significant impact and develop their careers.

    Position Overview
    The Medical Safety Science Director reports to the Head of Global Medical Safety Science and is responsible for overseeing all pharmacovigilance (PV) activities related to Ascendis products. This individual will ensure compliance with all applicable regulations and contribute to patient safety monitoring.

    Key Responsibilities

    • Assist the Head of Global Medical Safety Science in ensuring corporate compliance with drug safety and pharmacovigilance activities, including regulatory reporting and risk management.
    • Lead assigned products through development and post-marketing, collaborating with internal teams to monitor safety and address potential issues.
    • Review all safety reports per ICH-GCP guidelines and company SOPs.
    • Conduct Quality Control reviews of safety cases to ensure accuracy and completeness in the safety database.
    • Liaise with Medical Monitors in Clinical Development to ensure thorough medical reviews of adverse event reports.
    • Analyze and report on safety trends and signals related to Ascendis and competitive products, utilizing single case reports, aggregate safety reports, and literature reviews.
    • Develop safety surveillance and risk management plans for drug development programs.
    • Contribute medical and safety input to expedited and aggregate safety reports, including 15-day Alert Reports and PSURs.
    • Negotiate safety data exchange agreements with partners to support pharmacovigilance processes.
    • Assist in preparing and revising product labeling and safety documentation for clinical studies and regulatory submissions.
    • Provide pharmacovigilance guidance and support for cross-departmental initiatives.
    • Ensure training and awareness of PV principles and policies among relevant personnel.
    • Stay updated on industry best practices and global safety regulations, recommending necessary changes to departmental policies.
    • Represent Ascendis during regulatory inspections and internal audits in coordination with the GCP and PV Compliance team.
    • Act as a PV advisor to various departments, including Clinical Development and Medical Affairs.
    • Lead responses to ad-hoc safety queries from regulatory authorities in collaboration with relevant stakeholders.
    • Participate in crisis management activities within the PV group.

    Requirements

    • Doctoral degree (MD, PhD, PharmD) required.
    • Minimum of 8 years of experience in the pharmaceutical industry with a strong understanding of pharmacovigilance processes.
    • Expert knowledge of FDA and EMA PV regulations, ICH guidelines, and global safety regulations.
    • Ability to travel up to 20% domestically and internationally.

    Salary
    Estimated salary range: $225,000 - $245,000 per year.

    Benefits

    • Medical, Vision, and Dental Insurance
    • 401(k) Plan
    • Paid Maternity and Paternity Leave
    • Commuter Benefits
    • Disability Insurance

    Note to Recruiters
    We do not accept unsolicited candidate presentations from external search firms. If candidates are presented without prior written permission from Ascendis Pharma’s Human Resources team, no ownership of those candidates will be acknowledged.

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