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

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

Ascendis Pharma

Hellerup, Denmark

We are seeking a passionate Safety Data Analysis and Reporting Lead 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 6 colleagues, and report directly to Head of GPS Medical Sciencewho is based in Germany.You will be based in Hellerup.

Your key responsibilities will be:

• 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.

Qualifications and Skills:

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.

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.