Pharmacovigilance Projects & Collaborations Lead — Associate Director

Ascendis Pharma

Hellerup

On-site

DKK 1,100,000 - 1,500,000

Full time

14 days+
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Job summary

Ascendis Pharma in Denmark seeks an Associate Director, Pharmacovigilance Projects & Collaborations to lead post-marketing PV programs and ensure global PV compliance across lifecycle activities. This role is based in Hellerup, with responsibility for PV processes, vendor oversight and cross-functional collaboration.

You will collaborate with GVP Compliance, Medical Affairs and affiliates to deliver PV training, drive inspection readiness, and support risk management initiatives in a fast-paced

Qualifications

  • Bachelor’s degree in a health-related field and 8+ years in Pharmacovigilance.
  • Expert knowledge of FDA safety regulations, ICH, GVP and global PV guidance.
  • Experience in cross-functional, matrixed environments and vendor oversight.

Responsibilities

  • Lead pharmacovigilance activities across lifecycle for Organized Data Collection programs.
  • Establish PV processes in collaborations and activities such as Digital Platforms and Call Centers.
  • Oversee vendor performance, risk, CAPA and regulatory compliance.
  • Develop, maintain PV SOPs and deliver PV training to stakeholders.

Skills

Pharmacovigilance
GVP knowledge
FDA regulations
Cross-functional

Education

Bachelor's degree in health-related discipline

Job description

Ascendis Pharma in Denmark seeks an Associate Director, Pharmacovigilance Projects & Collaborations to lead post-marketing PV programs and ensure global PV compliance across lifecycle activities. This role is based in Hellerup, with responsibility for PV processes, vendor oversight and cross-functional collaboration.

You will collaborate with GVP Compliance, Medical Affairs and affiliates to deliver PV training, drive inspection readiness, and support risk management initiatives in a fast-paced

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