Medical Safety Specialist

About the role

The Medical Safety Specialist supports Sandoz’s delivery activities by co‑authoring safety documents, providing safety input to regulatory and clinical submissions, and responding to health authority queries. The role also monitors product safety through literature reviews, case evaluations and signal detection.

Key responsibilities

• Co‑author safety sections of regulatory and clinical documents and respond to ad‑hoc health authority queries.
• Monitor product safety profiles via literature review, medical case evaluation and signal detection.
• Prepare and follow up on health authority assessment reports and short‑term notice requests.
• Support safety input for new indication submissions and regulatory documents.
• Respond to internal safety requests and external safety queries.
• Maintain and manage local deviations and other safety deliverables as assigned.
• Act as Subject Matter Expert for Medical Operations, mentor junior colleagues, and lead training.
• Oversee distribution of marketing samples where applicable.

Required profile

• Ability to manage crises and people challenges.
• Broad functional knowledge across medical and safety domains.
• Strong collaboration across boundaries and functional teams.
• Experience in operations management, execution and project management.
• Understanding of clinical research and clinical trials processes.

Required skills

• Literature review
• Medical records handling
• Process safety
• Regulatory compliance
• Safety science
• Clinical research
• Clinical trials

What we offer

• Opportunity to work for a global leader in generic and biosimilar medicines.
• Access to a collaborative, open culture that supports personal growth.
• Flexible‑hybrid career options within a diverse and inclusive environment.