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    Director, Medical Safety Science - Job Id: Dmss

    Ascendis Pharma
    8+ years
    $225,000 - $245,000 per year
    Palo Alto
    10 Oct. 1, 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

    Ascendis Pharma: Medical Safety Science Director Position

    Ascendis Pharma is a dynamic and rapidly growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. We are currently advancing programs in Endocrinology, Rare Diseases, and Oncology.

    At Ascendis, we pride ourselves on exceptional science, visionary leadership, and a team of skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we leverage our TransCon® drug development platform to fulfill our mission of creating innovative therapies that address unmet medical needs.

    Our culture fosters an environment where adaptable and resourceful professionals can truly make their mark. We provide a dynamic workplace that encourages employees to grow and develop their skills.

    Position: Medical Safety Science Director

    Reporting To: Head of Global Medical Safety Science

    Role Overview:
    The Medical Safety Science Director is responsible for all pharmacovigilance (PV) related activities for Ascendis products. This individual will ensure compliance with applicable laws and regulations and oversee safety monitoring activities.

    Key Responsibilities:

    • Assist the Head of Global Medical Safety Science in drug safety and pharmacovigilance activities to ensure compliance with corporate standards and local regulatory requirements, including signal detection and risk management.
    • Support the Pharmacovigilance Department in maintaining standards and processes for safety monitoring activities.
    • Take a leadership role for assigned products, collaborating with key stakeholders to monitor patient safety and provide recommendations on potential safety issues.
    • Ensure all safety reports are reviewed in accordance with ICH-GCP guidelines, regulatory requirements, and company SOPs.
    • Conduct quality control reviews of assigned cases for accuracy, integrity, and completeness of information in the safety database.
    • Liaise with Medical Monitors in Clinical Development for appropriate medical assessments of adverse event reports and safety findings.
    • Analyze and report on trends and concerns regarding Ascendis products and competitive products, including safety signal evaluation through case reports and aggregate safety reports.
    • Lead the development of safety surveillance and risk management plans for drug development programs.
    • Provide medical and safety input for expedited and aggregate safety reports (e.g., 15-day Alert Reports, SUSAR, PSUR, US PADER, Annual Safety Reports, DSUR, IND Annual Reports).
    • Negotiate safety data exchange and pharmacovigilance agreements with license partners and distributors.
    • Assist in preparing and revising product labeling and safety sections of relevant documentation, ensuring accurate representation of product safety profiles.
    • Collaborate with various departments to provide pharmacovigilance guidance for corporate initiatives.
    • Ensure training and awareness of PV and Drug Safety principles among company personnel and external groups.
    • Monitor industry best practices and global safety regulations, recommending updates to departmental policies and SOPs.
    • Represent Ascendis during regulatory inspections or internal audits related to pharmacovigilance.
    • Serve as a PV advisor to Clinical Development, Medical Affairs, and Commercial teams.
    • Respond to ad-hoc safety queries from Regulatory Authorities in a timely manner, ensuring stakeholder involvement.
    • Participate in relevant crisis management activities within the PV group.
    • Collaborate with the Head of Global Drug Safety and colleagues in the EU and US on safety issues.

    Requirements:

    • Doctoral degree (MD, PhD, PharmD, or equivalent) is required.
    • 8+ years of experience in the pharmaceutical industry with a strong understanding of pharmacovigilance processes.
    • Expertise in FDA and EMA PV regulations, ICH Guidelines, and other relevant regulatory documents; familiarity with global safety regulations is essential.
    • Willingness to travel up to 20% domestically and internationally.

    Estimated Salary: $225,000 - $245,000 per year

    Note to Recruiters:
    We do not accept unsolicited candidate submissions from external search parties. Presentation of candidates without prior written consent from Ascendis Pharma's Human Resources team (specifically from the Talent Acquisition Partner or Human Resources Director) will not be recognized.

    Benefits:

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

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