Drug Safety Case Specialist (m/w/d)

About the role

Join a high‑performing Product Safety & Risk Management team and take responsibility for the end‑to‑end processing and reporting of serious adverse events (SAEs) and pregnancy cases from clinical trials. You will ensure timely, compliant, and high‑quality safety case management in line with global regulatory requirements.

Key responsibilities

• Manage the full lifecycle of safety cases: triage, data entry, MedDRA coding, narrative writing, quality review, and expedited SAE submission.
• Monitor daily workloads, prioritize tasks, and meet strict global regulatory timelines.
• Represent Drug Safety in Clinical Trial Team meetings and collaborate with Drug Safety Physicians.
• Partner with Data Management to reconcile SAE data between clinical and safety databases.
• Coordinate safety submissions to regulatory authorities, investigators, ethics committees, and data monitoring committees.
• Maintain 100% compliance with Quality System documents, SOPs, and procedural requirements.

Required profile

• Bachelor’s degree in Life Sciences (Pharmacy, Nursing, Biomedical Sciences); Master’s preferred.
• 1–2 years of hands‑on experience in Drug Safety, Pharmacovigilance, or Clinical/Safety Data Management.
• Strong medical terminology knowledge and familiarity with drug coding dictionaries, especially MedDRA.
• Understanding of EU and US safety reporting requirements is a strong advantage.
• Exceptional organizational and problem‑solving abilities, able to work under pressure and meet short regulatory deadlines.
• Advanced proficiency in written and spoken English.

Required skills

• MedDRA coding
• Adverse event coding
• Safety case management
• Regulatory reporting

What we offer

• Hands‑on clinical safety experience within a collaborative matrix structure.
• Opportunities to develop purpose‑driven career in a culture that values courage and resilience.