Safety Surveillance Specialist

Description

• Prepare safety contributions to study reports, regulatory submissions, protocols, and other key documents
• Lead strategic and scientifically responses to safety Q&A from all HA interactions
• Lead analytical and medical evaluation of aggregate safety data
• Represent Safety Surveillance in cross-functional project teams and at external meetings
• Work closely with colleagues across Clinical Development, Medical & Science, Regulatory Affairs, Biostatistics, and other functional areas
• Contribute to benefit–risk communication and ensure clear, aligned and timely safety messaging for internal stakeholders and Health Authorities

Qualifications

Highest qualification: University

• A master’s degree in Life Sciences (e.g. Pharmacy, Medicine, Veterinary Medicine, or Biology); a PhD and/or specialist clinical experience is considered an advantage
• Solid experience within drug safety, pharmacovigilance, drug development processes, global regulatory requirements, GxP standards, and medical concepts
• Proven ability to identify challenges, shape strategies, and translate them into clear, actionable steps
• Strong stakeholder management and the ability to influence decisions through clear, concise communication
• Demonstrated ability to communicate clearly, both in writing and verbally, and to translate complexity into clear recommendations
• A self-driven, ethical, and adaptable approach — you work independently, address issues proactively, and maintain flexibility when situations or priorities change
• A true team player who demonstrates empathy, takes care of colleagues, builds effective connections, and collaborates seamlessly with both internal and external stakeholders