Senior Pharmacovigilance Operations Manager

4 weeks ago


Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

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.



  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    We 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...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Job OverviewWe are seeking a highly skilled Senior Pharmacovigilance Compliance Manager to join our team at Ascendis Pharma.


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Job Title: PSMF & QPPV Office ManagerJob Summary:We are seeking a highly skilled and experienced PSMF & QPPV Office Manager to join our team at Ascendis Pharma. As a key member of our global PV system, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office, providing oversight and guidance of the QPPV Office operations, and...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Pharmacovigilance Operations RoleAbout the JobAscendis Pharma, a leading biotech company, is seeking a dedicated Pharmacovigilance Operations Specialist to join its Global PV Operations team. This role will provide strategic and operational PV/quality/safety support for the company's portfolio of products.Key ResponsibilitiesSupport product launch activities...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Role OverviewAt Ascendis Pharma, we are seeking an experienced and skilled QPPV Office Manager to join our team. In this role, you will be responsible for ensuring the day-to-day operations of the QPPV Office, supporting the QPPV and deputy QPPV in maintaining our global PV system, including its quality system.As a key member of our team, you will contribute...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Clinical Development Opportunity at Ascendis PharmaWe are seeking a passionate Clinical Trial Manager to join our growing team at Ascendis Pharma, a fast-growing biopharmaceutical company with a strong presence in Denmark, Germany, and the United States. Our TransCon technology is driving innovation in the field of rare endocrine diseases, and we are...


  • Hellerup, Gentofte Kommune, Denmark Novo Nordisk Foundation Full time

    About the RoleWe are seeking a highly skilled Senior Specialist to join our P&O Operations team at the Novo Nordisk Foundation. As a key member of our team, you will play a critical role in supporting the Foundation's global expansion by focusing on well-defined lean global P&O processes and global P&O operation support.Main Responsibilities:Design and...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Ascendis Pharma is a rapidly growing biopharmaceutical company with operations in multiple locations across the globe. Our mission is to develop innovative therapies that make a meaningful difference in patients' lives.We are seeking an experienced Senior Medical Device Quality Assurance Manager to join our team. This role will be responsible for ensuring...


  • Hellerup, Gentofte Kommune, Denmark Novo Nordisk Foundation Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Scientific Manager to join our Infectious Diseases Programme Area at the Novo Nordisk Foundation. As a key member of our team, you will be responsible for developing and managing a portfolio of projects within clinical infectious diseases research and antimicrobial resistance (AMR).Key...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    The Competitive Intelligence department at Ascendis Pharma plays a vital role in maintaining a competitive edge in the industry. As a Senior Manager Competitive Intelligence, you will be responsible for leading competitive intelligence efforts, collecting and analyzing data to create a unified understanding of the market landscape.Key responsibilities...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Job Summary: We are seeking a highly skilled Senior Project Manager to join our team at Ascendis Pharma. As a key player in our packaging operations, you will be responsible for establishing, reviewing, and maintaining requirements, specifications, risk analyses, and procedures to ensure safe products and efficient manufacturing processes.Key...


  • Hellerup, Gentofte Kommune, Denmark Novo Nordisk Foundation Full time

    Job Title: Global IT Operations DirectorAbout the Role:We are seeking an experienced Global IT Operations Director to join our team at the Novo Nordisk Foundation. As a key member of our IT department, you will be responsible for managing the global IT service and operations setup in our international offices.Key Responsibilities:Manage the global IT service...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    The Competitive Intelligence department at Ascendis Pharma plays a crucial role in keeping the business informed about the competitive landscape and supporting sustainable growth. A key member of this team will be the Senior Competitive Intelligence Manager.This individual will be responsible for gathering, analyzing, and disseminating information to create...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Are you passionate about clinical development?Ascendis Pharma is a fast-growing biopharmaceutical company with a strong focus on making a meaningful difference in patients' lives.We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company. Guided by our core values of patients, science, and passion, we use our...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Transforming Clinical DevelopmentAscendis Pharma is a fast-growing biopharmaceutical company seeking a seasoned Clinical Trial Manager to join our Clinical Operations team. As a key member of our team, you will play a crucial role in planning and executing clinical trials within rare endocrine diseases.Key Responsibilities:Lead clinical trials and ensure...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Lead Global Financial OperationsA key member of the Ascendis Pharma Finance team, you will play a leading role in our Transfer Pricing setup, monitoring and controlling, handling and optimizing the operating side in close cooperation with Tax and Finance Systems.Key ResponsibilitiesEnsure compliance with Ascendis Transfer Pricing policy and process...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    About the RoleWe are seeking a highly skilled and experienced QA Medical Device Senior Manager to join our team at Ascendis Pharma. As a key member of our QA organization, you will play a crucial role in ensuring the quality and compliance of our medical devices and drug-device combination products.Key ResponsibilitiesDevelop and implement QMS improvement...


  • Hellerup, Gentofte Kommune, Denmark Ascendis Pharma Full time

    Medical Safety Science LeaderAscendis Pharma is seeking a highly skilled Medical Safety Science Leader to join our team. As a key member of our Medical Safety Science team, you will be responsible for ensuring the safety of our products and providing leadership in the development of safety surveillance and risk management plans.Key Responsibilities:Lead the...


  • Hellerup, Gentofte Kommune, Denmark Novo Nordisk Foundation Full time

    Job DescriptionWe are seeking an experienced Global IT Operations Lead to drive the continued development of our global IT service. This role will be responsible for managing all aspects of the global IT service and activities related to our international expansion.About the RoleThis is a unique opportunity to join our Corporate IT Team as a Global IT...


  • Hellerup, Gentofte Kommune, Denmark emagine Consulting Full time

    Key Responsibilities:We are seeking a Project Manager for selection of new KYC system for one of our clients in the financial sector.Must have skills:Knowledge and experience from the financial industryKnowledge within KYC case management systemsExperience with vendor selectionsExperience with vendor scanning the market for case managementProject...