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Associate Director, Global Pv Operations - Job Id: Gpv

7+ years
Not Disclosed
10 March 19, 2025
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, Global Pharmacovigilance Operations
Location: [Insert Location]


Company Overview:

Ascendis Pharma is a rapidly growing global biopharmaceutical company with a presence in Denmark, Europe, and the United States. Our mission is to develop new, potentially best-in-class therapies that address unmet medical needs, with a strong focus on Endocrinology, Rare Diseases, and Oncology. At Ascendis, we pride ourselves on exceptional science, visionary leadership, and a team of skilled and passionate professionals.

We foster a dynamic workplace where professionals can make their mark, offering opportunities to grow, develop skills, and contribute meaningfully to advancing healthcare.


Key Responsibilities:

  • Study Management Support: Act as an active member of Study Management Teams (SMTs) representing the PV Operations team, supporting both Sponsored and Investigator Initiated Trials.
  • Review Study Documents: Review key study documents such as Study Protocols, Safety Management Plans (SMPs), Data Management Plans, etc.
  • SAE Reconciliation: Support SAE reconciliation activities for assigned studies as needed.
  • Study Classification: Oversee study classification, including interventional, non-interventional, and Post Approval Safety Studies (PASS).
  • PV Vendor Oversight: Ensure PV vendors/service providers meet their responsibilities, ensuring adherence to global/local regulatory requirements and Ascendis policies.
  • Case Processing: Provide expertise and strategic input regarding the processing of Individual Case Safety Reports (ICSRs) and oversee operational activities related to ICSR processing.
  • Training & Documentation: Develop training materials (e.g., SOPs) and provide education to internal stakeholders and vendors.
  • Regulatory Compliance & Reporting: Support the preparation of safety reports (e.g., SUSAR, PSUR, DSUR, etc.) and ensure compliance with pharmacovigilance requirements across vendors and service providers.
  • Cross-functional Collaboration: Work with Clinical Development, Medical Affairs, and other teams to ensure safety requirements are met for Ascendis products.
  • Oversight of Patient Support Programs (PSPs): Contribute to the oversight and compliance of PSPs and other service providers.
  • Crisis Management: Participate in crisis management activities related to pharmacovigilance.
  • Risk Management Plan Coordination: Coordinate the implementation of risk management plans and associated tracking.

Competencies for Success:

  • Strong organizational skills and attention to detail in a fast-paced environment.
  • Demonstrated ownership, initiative, and accountability.
  • Ability to work independently and collaborate effectively within cross-functional teams.
  • Excellent communication skills, both verbal and written.
  • Strong strategic evaluation and decision-making skills.
  • High level of commitment and adaptability in dynamic situations.

Minimum Qualifications:

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

Benefits:

  • 401(k) plan with company match
  • Medical, dental, and vision plans
  • Life and AD&D insurance
  • Short- and long-term disability benefits
  • Pet insurance and Legal insurance
  • Employee Assistance Program and Discounts
  • Professional development support
  • HSA and FSA options
  • Incentive compensation plans
  • Mental health resources
  • Paid leave for new parents