Senior Manager, Safety Data Analysis and Reporting

Are you passionate about Patient Safety? Do you have experience within periodic safety reports and safety data analysis?

If so, now is your chance to join Ascendis Pharma as our new Senior Manager, Safety Data Analysis and Reporting.

Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.

At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Senior Manager, Safety Data Analysis and Reporting to join our growing team. As a key member of the Ascendis Pharma team, you will play a crucial role in leading the preparation of the periodic safety reports. 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 GPS Medical Science Team consisting of colleagues, and report directly to Head of GPS Medical Science who is based in Germany. You will be based in Hellerup.

Your key responsibilities will be:

• Oversee and own the planning of aggregate reports and risk management plans, ensuring quality and compliance with SOPs and submission timelines.
• Support the kick-off, writing, and execution of aggregate reports and risk management plans, ensuring quality and compliance with SOPs and submission timelines.
• Coordinate with the vendor to ensure timely and effective completion of all activities related to aggregate reports and risk management plans.
• Support the collection and analysis of safety data from multiple sources to ensure comprehensive safety evaluations and reporting.
• Work collaboratively across different GPS teams including GPSO and QPPV Office.
• Work with program safety leads to provide essential safety inputs for periodic safety reports, safety assessments, and responses to health authority requests.

Qualifications and Skills:

You hold a relevant academic degree – preferably a Master degree in a relevant life science field (e.g., pharmacy, nursing, or medicine) – and at least 3 years of experience within patient safety.

Furthermore, you have:

• Good expertise in safety data analysis, aggregate safety reporting, regulatory compliance, and risk management.
• Solid working knowledge of FDA and EMA pharmacovigilance regulations, ICH Guidelines, and other relevant global safety regulations and guidance documents.

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 strong communicator and have excellent organizational skills.

Travel: up to 20 days per year.

Office: Denmark, Hellerup.

Apply now.

We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.

To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.

For more details about the position or the company, please contact Elian Khazneh, Head of GPS Medical Science ([email protected])

You can learn more about Ascendis by visiting our website www.ascendispharma.com

Applications must be submitted in English and will be treated confidentially.

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.