Program Safety Lead

Program Safety Lead

Ascendis Pharma

Hellerup, Denmark

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.

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.

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