Associate Director, Pharmacovigilance Projects & Collaborations

About the role

Ascendis Pharma is seeking an Associate Director to lead pharmacovigilance projects and collaborations for post‑marketing programs. Based in Hellerup, Denmark, you will work with global cross‑functional teams to ensure compliance with PV regulations.

Key responsibilities

• Lead pharmacovigilance activities across the lifecycle of Organized Data Collection programs for marketed products, ensuring regulatory compliance.
• Partner with internal stakeholders to establish PV processes for digital platforms, call centers, and other initiatives.
• Provide strategic input on vendor contracts, adverse event handling, and timelines.
• Oversee service provider performance, risk identification, monitoring, and CAPA implementation.
• Collaborate with GVP Compliance, Commercial, Medical Affairs, and affiliates to maintain consistent global PV practices.
• Develop, maintain, and own global PV SOPs and training materials; deliver training to internal and external stakeholders.

Required profile

• Minimum 8 years of pharmacovigilance experience in the pharmaceutical industry.
• Strong knowledge of FDA safety regulations, ICH guidelines, and GVP requirements.
• Experience working in cross‑functional, matrixed environments with a focus on compliance and inspection readiness.
• Analytical, entrepreneurial mindset with the ability to work independently and as part of a team.

Required skills

• Pharmacovigilance regulatory expertise (FDA, ICH, GVP).
• Vendor management and oversight.
• Development and delivery of SOPs and training materials.
• Risk assessment and CAPA implementation.