Medical Safety Expert

About the role

Sandoz is seeking a Medical Safety Expert to support the safety monitoring and regulatory compliance of its pharmaceutical products. The role involves preparing safety documentation, responding to health authority queries, and acting as a subject‑matter expert for medical operations.

Key responsibilities

• Co‑author safety sections of regulatory and clinical documents and respond to ad‑hoc health authority queries.
• Monitor product safety profiles through literature reviews, case evaluations and signal detection.
• Prepare and follow up on Health Authority Assessment Reports and short‑term notice requests.
• Support new indication submissions with safety input and maintain local deviation management.
• Provide internal safety responses and contribute to external safety queries.
• Lead training and mentoring of junior team members.
• Distribute marketing samples where applicable.

Required profile

• Minimum 8 years of relevant experience in drug safety, pharmacovigilance or related fields.
• Proven ability to manage crises and handle complex safety issues.
• Strong collaboration skills across functional boundaries.
• Experience in project and operations management within a medical or regulatory environment.

Required skills

• Literature Review
• Medical Records analysis
• 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.
• Collaborative, inclusive culture with flexible‑hybrid career paths.
• Access to professional development and mentorship programs.