Associate Director, Global PV Operations

4 weeks ago


Palo Alto, California, United States Ascendis Pharma Full time
Job Summary

The Associate Director, Global PV Operations is responsible for leading the Pharmacovigilance (PV) Operations team at Ascendis Pharma. This role requires a strong background in drug safety and regulatory compliance, with a focus on ensuring the timely and accurate collection, processing, and reporting of adverse event data.

Key Responsibilities
  • Lead the PV Operations team in the conduct of sponsored and investigator-initiated trials for Ascendis products
  • Oversee the review of study documents, including study protocols, safety management plans, and data management plans
  • Support SAE reconciliation activities for assigned studies
  • Classify studies as interventional, non-interventional, or post-approval safety studies
Additional Responsibilities
  • Oversee PV vendors/service providers to ensure they fulfill their accountabilities and responsibilities
  • Act as a subject matter expert in processing individual case safety reports (ICSRs) and provide strategic input on case processing activities
  • Ensure adverse events from spontaneous cases, solicited cases, and studies are collected, reported, and handled in accordance with global/local regulatory requirements and company policies
Requirements
  • 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 other applicable regulatory guidance documents


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