Safety Data Analysis and Reporting Lead, Ascendis Pharma/1941

The Company
Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by their core values of Patients, Science, and Passion, they are applying their innovative TransCon® technology platform to fulfill their mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs. See more at https://ascendispharma.com

On behalf of our client, Best Talent is now searching for a Safety Data Analysis and Reporting Lead, Global Patient Safety Medical Science to join this growing and dynamic team both globally as well as in Hellerup.

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

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.

Safety Data Analysis and Reporting Lead,
Global Patient Safety Medical Science

You are passionate about Patient Safety
You are experienced within periodic safety reports and safety data analysis
The chance is now to join a group of dedicated co-workers aiming at excellence

The Challenge
The company is seeking a passionate Safety Data Analysis and Reporting Lead to join their 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.

In the role, Safety Data Analysis and Reporting Lead, your key responsibilities are:

Lead and oversee the planning, 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
Lead the collection and analysis of safety data from multiple sources to support comprehensive safety evaluations and reporting
Collaborate with program safety leads to provide essential safety inputs for periodic safety reports, safety assessments, and responses to health authority requests

Your Profile & Talent
You hold a relevant academic degree – preferably a Master or PhD degree in a relevant life science field (e.g., pharmacy, nursing, or medicine) – and at least 5 years of experience within patient safety.

Furthermore, you have:

Extensive 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

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, they also expect you to be a strong communicator and have excellent organizational skills. Travel: up to 20 days per year.

Application
Best Talent is managing the recruitment process on behalf of Ascendis Pharma and will handle all applications with the strictest confidence. Please send your application in English, clearly marking it "1941/ Safety Data Analysis and Reporting Lead", to job@besttalent.dk. Interviews will be conducted on a rolling basis, so please apply as soon as possible as this is a position of high urgency. For more information about Best Talent, please visit www.besttalent.dk.