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    Associate Director, Global Pv Operations

    Ascendis Pharma
    8+ years
    $185,000 - $210,000 per year
    Remote, USA
    10 Sept. 27, 2024
    Job Description
    Job Type: Remote 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

    Position: Associate Director, Global PV Operations

    Reports To: Head of Global PV Operations
    Location: [Specify Location]

    Job Description:
    The Associate Director of Global Pharmacovigilance (PV) Operations is responsible for overseeing all drug safety-related activities for Ascendis’ product portfolio. This role entails collaboration with Study Management Teams and external vendors to ensure compliance with global regulatory requirements and internal policies.

    Key Responsibilities:

    • Support Study Management Teams (SMTs):

      • Actively represent the PV Operations team in Sponsored and Investigator Initiated Trials.
      • Review essential study documents, including Study Protocols, Safety Management Plans (SMPs), and Data Management Plans.
      • Support Serious Adverse Event (SAE) reconciliation activities for assigned studies.
      • Classify studies appropriately (e.g., interventional, non-interventional, Post Approval Safety Studies).

    • Vendor Oversight:

      • Oversee PV vendors and service providers to ensure they meet their obligations.
      • Serve as a Subject Matter Expert (SME) on Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities.
      • Ensure collection, reporting, and handling of adverse events from various sources in accordance with regulatory requirements and company policies.
      • Provide guidance and feedback on operational activities related to ICSR processing by PV vendors.
      • Develop training materials (e.g., SOPs) for targeted audiences as needed.
      • Advise Ascendis Clinical Development, Medical Affairs, and Commercial teams on PV matters.
      • Ensure timely ICSR submissions are maintained.

    • Pharmacovigilance Oversight:

      • Manage GVP and Patient Support Programs (PSPs) vendors under the guidance of the Head of Global PV Operations.
      • Liaise with functional units to identify Market Research and Patient Support Programs (MAPs) and ensure compliance with PV requirements.
      • Maintain oversight of Source Data Quality Check (SDQC) and Case Transmission Verification (CTV) activities.
      • Conduct training sessions to enhance awareness of pharmacovigilance requirements.
      • Identify compliance risks and develop action plans.
      • Support the implementation of Corrective and Preventive Actions (CAPAs) as necessary.
      • Collaborate with the GCP/PV Compliance team to ensure effective oversight.

    • Additional Activities:

      • Represent the PV team during regulatory inspections or internal audits.
      • Collaborate with the Medical Safety Science team on assigned activities.
      • Manage Risk Management Plan implementation and associated tracking.
      • Maintain oversight of activities within the PV group under the direction of the Head of Global PV Operations.
      • Participate in crisis management activities as needed.

    Competencies for Success:

    • Effective independent and collaborative work style.
    • Strong organizational skills, detail-oriented, and adaptable in a fast-paced environment.
    • Demonstrates ownership, initiative, and accountability.
    • Excellent teamwork and communication skills, both written and verbal.
    • Strong strategic evaluation, analysis, and decision-making capabilities.
    • High level of commitment to the organization’s goals.

    Requirements:

    • Master’s degree in a healthcare-related field with relevant pharmaceutical industry experience in drug safety.
    • Minimum of 8 years of recent experience in Pharmacovigilance.
    • Expert knowledge of FDA safety regulations, ICH Guidelines, and other relevant regulatory guidance; working knowledge of global safety regulations.
    • Ability to travel domestically and internationally up to 20% of the time.

    Estimated Compensation: $185,000 - $210,000 per year

    Benefits:

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

    Ascendis is an equal opportunity employer, committed to fostering an inclusive environment for all employees.

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