Director, Global PV Operations (00041)

Job Description

Ensure the PV operations for Ascendis Pharma portfolio products meet company objectives and comply with applicable regulations, policies and safety plans. Review study documents (Study Protocol, Safety Management Plans (SMPs), Data Management Plan (DMPs), and similar) and serious adverse events (SAE) reconciliation activities for assigned studies. Participate in sponsored and investigator initiated trials. Provide study classification, such as interventional studies, non-interventional studies, and post approval safety studies (PASS). Track Key Performance Indicators (KPIs) to ensure quality of key deliverables. Ensure PV vendors and service providers meet company business objectives. Process individual case safety reports (ICSRs) and provide strategic input on case processing activities for Ascendis products. Track aggregate reporting activities, such as pharmacovigilance database listings, data distribution to CROs and safety vendor, and submission tracking. Collaborate with GCP, PV Compliance and Medical Safety Science teams on PV related regulatory inspections, internal quality assurance and corporate compliance audits. Implement Risk Management Plan and participate in crisis management activities within the PV group. Domestic and international travel required 20% of time to California and Denmark offices and vendor site visits, as needed. May work full-time remote from anywhere in the U.S.

Qualifications

• Master’s degree (U.S. or foreign equivalent) in Healthcare Management, Life Sciences, or related healthcare or life sciences field and eight (8) years of experience in the job offered or a related Pharmacovigilance role. • Must have eight (8) years of prior experience in/with: strategy, design and implementation of pharmacovigilance programs; reviewing SUSAR SAE cases for regulatory reporting; ensuring PV and drug safety regulatory compliance in cross-functional clinical studies; supporting drug safety related activities related to new drug applications and regulatory filings; working with Food & Drug Administration (FDA) safety regulations, ICH guidelines, and similar regulatory guidance documents; working with global safety regulations, including FDA, EMA and MHRA; performing case processing for clinical studies, literature; and triaging ICSRs to qualify for expedited regulatory reporting. • Domestic and international travel required 20% of time to California and Denmark offices and vendor site visits, as needed.

Benefits

• Medical insurance • Vision insurance • Dental insurance • 401(k) • Paid maternity leave • Paid paternity leave • Commuter benefits • Disability insurance