PSMF & QPPV Office Manager

2 months ago

Gentofte Kommune, Denmark ASCENDIS PHARMA AS Full time

Are you passionate about pharmacovigilance and compliance management? Do you have experience in a drug safety environment with pharmacovigilance operational responsibilities?

If so, now is your chance to join Ascendis Pharma as our new PSMF & QPPV Office Manager

Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States.

We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Today, we have a growing pipeline of prodrug therapies in development, each designed to be a best-in-class therapy.

We are seeking a passionate QPPV Office Manager to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in ensuring the day-to-day operations of the QPPV Office. You will support the QPPV and deputy QPPV in maintaining Ascendis Pharma’s global PV system including its quality system, providing oversight and guidance of the QPPV Office operations and contribute to improvements projects and innovation. Moreover, you will be responsible for the maintenance of the PSMF and provide PSMF related subject matter expertise.

This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.

You will be joining the QPPV Office team consisting of 2 colleagues, and report directly to Eva Widebæk Rasmussen, Sr. Director & QPPV who is based in our office in Hellerup.

Your key responsibilities will be:

  • Ensure overall compliance of the PV system and stay up-to-date with legislation including drive PV intelligence activities
  • PSMF coordination, preparation and maintenance with key stakeholders in accordance with assigned schedule and current legislation including local PSMFs
  • Oversight and management of deviations and CAPAs
  • Lead and contribute to the improvements of QPPV and PSMF-related processes and prepare and maintain procedural documents
  • Support collaboration with vendors and distributors, including contractual agreements (SDEAs)
  • Be part of ensuring inspection readiness

Qualifications and Skills:
You hold a relevant academic degree or similar e.g. Master within a health care field, nursing and have at least 3 years of experience within pharmacovigilance. You have solid knowledge of EMA & FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents.

You have solid experience with MS office including MS excel, Adobe Acrobat, and Sharepoints management.

Furthermore, you have:

  • Experience with managing the EEA and UK PSMF
  • Ability to identify and implement process improvements
  • Ability to work on multiple simultaneous tasks with limited supervision

Key competencies:
You are a strong team player but also thrive in solving tasks independently, work systematically and with an eye for details and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal, open environment where innovation and change are key.

To succeed in this role, we also expect you to be:

  • Responsible and prioritize quality in your work
  • Like challenges but also thrive on routine tasks
  • Good at building relationships even at a distance
  • Have good communication skills, both written and verbal

Travel: 10-15 days per year.

Office: Ascendis Pharma Headquarter, Hellerup

Apply now.
Applications will be evaluated when received, so please apply as soon as possible.

All applications must be submitted in English and are treated confidentially.

For more details about the position or the company, please contact Eva Widebæk Rasmussen, Sr. Director & QPPV, or visit out website

Hellerup

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