Senior Director, Global Patient Safety QPPV at Ascendis Pharma

Gentofte Municipality, Capital Region of Denmark, Denmark -

Full Time

Start Date

Immediate

Expiry Date

12 Jan, 26

Salary

0.0

Posted On

14 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Patient Safety, Compliance, Signal Management, Drug Safety, Team Leadership, Analytical Skills, Communication Skills, Interpersonal Skills, Strategic Planning, Safety Reporting, Safety Databases, ICSR Management, Entrepreneurial Mindset, MS Office, English Proficiency

Industry

Biotechnology Research

Description

Are you passionate about patient safety? Do you have experience within Pharmacovigilance? If so, now is your chance to join Ascendis Pharma as our new Qualified Person for Pharmacovigilance (QPPV). Ascendis Pharma is a fast-growing global biopharmaceutical company committed to making a meaningful difference in patient’s lives. We have locations in Denmark, Germany, the United States, the UK, Italy, Spain, and France. Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new therapies, selecting only those that demonstrate best-in-class potential to address unmet medical needs. Today, we are advancing programs in Endocrinology Rare Disease and Oncology. In addition, we collaborate with partners around the world on the development of TransCon-based products for other therapeutic areas and markets. We are seeking a passionate EU QPPV to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in the oversight into the functioning of the PV system in all relevant aspects. 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 Global Patient Safety team consisting of ~20 colleagues, and report directly to VP, Head Global Patient Safety who is based in Palo Alto, California, USA. You will be based in EU territory (preferably in Hellerup, Denmark). Your key responsibilities will be: To influence the performance of the quality system and the PV activities. To promote, maintain and improve compliance with the legal requirements. To maintain an overview of medicinal product safety profiles and any emerging safety concerns via signal management process. To ensure that the conduct of PV and submission of all PV-related documents are in accordance with the legal requirements and GVP. As the head of QPPV office, lead the QPPV team to fulfill specific tasks as required. Qualifications and Skills: You hold a relevant academic degree – preferably a relevant academic degree in medicine, pharmacy, or the life sciences and 8+ years of experience within pharmacovigilance and 5+ years of management experience in a Drug Safety organization. Furthermore, you have: Proficiency in English at a professional level, both written and spoken, and you master MS Office. Strategic proficiency in crafting approaches to maintain compliance with relevant EMA, FDA, ICH guidelines, initiatives and regulations governing both clinical and post-marketing Safety reporting. Knowledge within Individual Case Safety Reports (ICSR) management processes including case receipt, case processing, medical review and regulatory submission. Solid experience with safety databases (e.g., ARGUS, ARISg etc.) and safety coding dictionaries (e.g., MedDRA, WHODRUG). Key competencies: You are a strong team player, analytical, 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: A highly motivated individual who enjoys being challenged and working in collaborative environments. You have strong analytical and communication skills and ability to make high-impact decisions. You have solid interpersonal skills and are good at establishing and maintaining working relationships. Furthermore, the position requires flexibility and the ability to work overlapping hours with colleagues based in Palo Alto, California Travel: 15-20 days per year. Office: Tuborg Havn in Hellerup, Denmark 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 Mandeep Singh, MD. V.P., Head of Global Patient Safety, mail: msh@ascendispharma.com You can learn more about Ascendis by visiting our website www.ascendispharma.com Applications submitted via email or other channels will not be reviewed.

Responsibilities

You will oversee the functioning of the pharmacovigilance system and ensure compliance with legal requirements. Additionally, you will lead the QPPV team to fulfill specific tasks as required.