Senior Pharmacovigilance Projects & Collaborations Lead

Ascendis Pharma; Gentofte Kommune; On-site; DKK 1,000,000 - 1,250,000; Full time

Job summary

Ascendis Pharma is seeking an Associate Director, Pharmacovigilance Projects & Collaborations to establish PV processes in post-marketing programs and ensure compliance with global PV regulations. The role is based in Hellerup, Denmark, leading PV activities across the lifecycle and collaborating with cross-functional, global teams.

You will manage vendor relationships, develop SOPs and training, support crisis management initiatives, and report to the Director, head of Pharmacovigilance Vendor

Qualifications

• Bachelor's degree in a health-related discipline.
• Minimum 8 years of pharmacovigilance experience in pharma.
• Expert knowledge of FDA safety regulations, ICH guidelines, GVP and global PV regulations.

Responsibilities

• Lead pharmacovigilance activities across the lifecycle of Organized Data Collection programs, ensuring compliance with global/local regulations and policies.
• Partner with internal stakeholders to identify PV processes in Organized Data Collection programs and Digital Platforms/Call Centers.
• Provide strategic input to PV setup and execution in programs, including vendor contracts, AE handling, and timelines.
• Ensure effective oversight and performance of service providers/vendors, including risk identification, monitoring and CAPA implementation.
• Oversee SDQC and CTV activities performed by service providers/vendors, ensuring timely completion and compliance.
• Collaborate with GVP Compliance, Commercial, Medical Affairs, and affiliates to ensure consistent PV practices globally and locally.
• Develop, maintain, and own global PV processes (e.g., SOPs) and related training materials; deliver PV training to internal and external stakeholders.
• Act as a PV subject matter expert, supporting stakeholders and contributing to broader PV activities, including vendor oversight areas and crisis management.

Skills

FDA regulations

ICH Guidelines

GVP requirements

PV regulatory guidance

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in health-related discipline

Job description

Ascendis Pharma is seeking an Associate Director, Pharmacovigilance Projects & Collaborations to establish PV processes in post-marketing programs and ensure compliance with global PV regulations. The role is based in Hellerup, Denmark, leading PV activities across the lifecycle and collaborating with cross-functional, global teams.

You will manage vendor relationships, develop SOPs and training, support crisis management initiatives, and report to the Director, head of Pharmacovigilance Vendor