Senior Pharmacovigilance Operations Manager
4 weeks ago
Role Summary
We are seeking a highly motivated and experienced Pharmacovigilance (PV) Operations Specialist to join our dynamic team at Ascendis Pharma.
As our new Associate Director / Director, Global PV Operations, you will be responsible for PV Operations activities and provide strategic and operational PV/quality/safety support for our portfolio of products in close collaboration with cross-functional colleagues.
Key Responsibilities:
- Support product launch activities in assigned territories.
- Collaborate effectively with Study Management Teams (SMTs) as an active member representing the PV Operations team.
- Manage and oversee PV vendors and service providers, including those involved in Patient Support Programs and Market Research Programs.
Requirements:
- A relevant academic degree, preferably a Bachelor's degree in a healthcare field.
- Several years of documented experience in Pharmacovigilance within the pharmaceutical industry.
- Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; global safety regulations knowledge is a plus.
- Proficiency in English at a professional level, both written and spoken.
Why Ascendis Pharma?
- Be part of a forward-thinking team committed to excellence in Pharmacovigilance.
- Engage in a role that offers both independence and teamwork in a dynamic setting.
- Opportunity to work closely with a global team and contribute to impactful projects.
Travel and Work Environment:
Travelling: 15 - 25 days a year.
Place of work: Ascendis Pharma resides in a wonderful office facility with a view to the harbor, the canals, and the sea.
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Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full timeWe are seeking an experienced and skilled Senior Director to join our Global PV Operations team at Ascendis Pharma. As a key member of the team, you will be responsible for overseeing PV operations activities and providing strategic support to our product portfolio in collaboration with cross-functional colleagues.This role offers an exciting opportunity to...
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