PSMF & QPPV Office Manager/Associate Director, Ascendis Pharma / 1897

PSMF & QPPV Office Manager/Associate Director

Ascendis Pharma A/S is a fast growing company, and on behalf of our client, Best Talent is now searching for a PSMF & QPPV Office Manager/Associate Director to join the PV team in this newly created position where you will play a key role in creation and maintenance of the Pharmacovigilance System Master File (PSMF) and all corresponding documents and annexes and local variation where required by local legislation.
The Company

Ascendis Pharma A/S, a U.S. publicly held, Biopharmaceutical company founded in Copenhagen, Denmark in 2007, committed to addressing unmet medical needs within the therapeutic area’s endocrinology and oncology. Ascendis Pharma is applying its innovative TransCon® technology to build a leading, fully integrated Biopharma company focused on developing new and potentially best-in-class therapies, making a meaningful difference in patients’ lives guided by their core values of patients, science, and passion. Headquartered in Copenhagen, Denmark, in a modern office facility in Tuborg Havn in Hellerup with a nice view of the harbor, the canals, and the sea. The company has offices in Germany and in the US. For more information about Ascendis Pharma read more: https://ascendispharma.com/

The Team
You will be joining the QPPV Office team in Denmark which consists of 2 colleagues with a cross functional responsibility. The QPPV Office team is part of the Global Pharmacovigilance & Global Drug Safety team with colleagues based in the US and Germany. You will report directly to the Senior Director & QPPV who is based in the office in Hellerup.

The Challenge
With profound experience in a drug safety environment, your role will be crucial 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 Pharmacovigilance PV system, including its quality system, providing oversight and guidance for the QPPV Office operations.

Your key responsibilities will include:

Ensuring overall compliance of the PV system and staying updated with legislation including driving PV intelligence activities
Coordinate, prepare and maintain the PSMF with key stakeholders, adhering to assigned schedules and current legislation including local PSMFs
Contributing to further building the compliance oversight and framework, incl. maintaining oversight and management of deviations and CAPAs
Leading and actively participate in process improvement initiatives in QPPV and PSMF-related processes as well as development and maintenance of relevant SOPs, WIs and supporting documents
Scheduling QPPV Oversight meetings, ensuring subject matter experts are present at QPPV oversight meetings, collating metrics/data for presentation at QPPV oversight meeting
Scheduling ad-hoc meetings with key partners where required, taking meeting minutesSupporting collaboration with vendors and distributors, including contractual agreements (SDEAs)
Facilitating and enhancing cross-functional communication with the QPPV Office and the global business Contributing to inspection readiness efforts

Talent
You hold a relevant academic degree, such as a Master´s in a health care related field, nursing or similar, and have at least 5 years of experience in pharmacovigilance. You possess solid knowledge about European pharmacovigilance legislation and other global pharmacovigilance requirements, FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents. You have strong proficiency in MS Office, including Excel, Adobe Acrobat, Veeva and SharePoint management.

This role might be for you if:
You are a strong team player who thrives in solving tasks independently, working systematically and with attention to detail. You approach your work with a positive, can-do attitude and an entrepreneurial mindset. Thriving in an informal, open environment where innovation and change are central to success, you have:

A responsible, quality driven approach to your tasks
Strong relationship-building skills, and the ability to build and lead collaborative partnerships even when working remotely, and enjoy working with multiple cross-functional stakeholders with diverse backgrounds
An analytical mindset and excellent communication skills in both English and Danish
Strong capability to manage multiple simultaneous tasks with limited supervision
Proven ability to identify and implement process improvements

Due to the company´s international growth and structure you should expect approximately 10 - 15 travel days per year and/or work hours in different time zones primarily the US, including the west coast. The company offers great flexibility to accommodate this.

Does this sound like you?
This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams to achieve extraordinary results.

Application
Best Talent is managing the recruitment process and will handle your application confidentially. Please forward your application in English marked ”1897/PSMF & QPPV Office Manager/Associate Director” to job@besttalent.dk. Interviews will be conducted on an ongoing basis, so please apply as soon as possible.

Read more about Best Talent at www.besttalent.dk. and Ascendis Pharma: www.ascendispharma.com