Program Safety Lead

Job title:

Program Safety Lead

Company:

Ascendis Pharma

Job description

Are you passionate about safety strategies? Do you have experience within the pharmacovigilance process?If so, now is your chance to join Ascendis Pharma as our new Program Safety LeadAscendis 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 Program Safety Lead to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in overseeing and managing pharmacovigilance activities for assigned drug development programs. This is an exciting opportunity to work in a fast-paced environment, collaborating with cross-functional, global teams working together to achieve extraordinary results.You will be joining the Global Patient Safety team consisting of 5 colleagues, and report directly to Dr. Elian Khazneh, Head of Global Patient Safety Medical Science who is based in Germany. You will be working out of our headquarters in Hellerup, so we expect you to be based in either Denmark or Sweden.Your key responsibilities will be:

• Oversee and manage pharmacovigilance activities for assigned drug development programs.
• Ensure compliance with global safety regulations, including EMA, FDA, and ICH guidelines.
• Lead the preparation and review of safety documents such as PSURs, DSURs, and safety sections of regulatory submissions.
• Collaborate with cross-functional teams to integrate safety data into clinical development plans.
• Provide safety expertise during regulatory inspections and audits.

Qualifications and Skills:You hold a relevant academic degree – preferably as a physician, pharmacist, or another healthcare professional with a doctoral qualification – and have at least 8 years of experience in pharmacovigilance.Furthermore, you have:

• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Experience in preparing and reviewing safety documents for regulatory submissions.
• Proficiency in using pharmacovigilance databases and safety reporting tools.
• Strong project management and organizational skills.
• Excellent communication skills, both written and verbal.

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 detail-oriented, proactive, and adaptable. Furthermore, this position requires flexibility and a few hours of overlapping work hours with colleagues based in Palo Alto, California.Travel: 15-25 days per year.Office: Tuborg Blvd. 12, 2900 HellerupApply 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 to Dr. Elian Khazneh, Head of Global Patient Safety Medical Science, elk@ascendispharma.comYou can learn more about Ascendis by visiting our websiteApplications submitted via email or other channels will not be reviewed.

Expected salary

Location

Hellerup, Hovedstaden

Job date

Thu, 08 May 2025 22:19:46 GMT

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