Senior Safety Scientist

Our client, a key player in the life sciences industry is looking for an Senior Safety Scientist to provide expert contribution to the development of the product safety strategy.

Responsibilities:

• Individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting
• Signal detection and management activities
• Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (incl, product quality) or in response to Regulatory Authority requests
• Provide expert contribution to the development of the product safety strategy
• Take independent responsibility for risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including IB), risk communications, RMP
• Review of clinical protocols, study reports, Investigator's Brochure (IB), informed consent form (ICF) and other related documents to ensure alignment with the safety strategy and ensure the appropriateness of risk management strategies and risk communication

Requirements:

• Qualified healthcare professional or Life Sciences graduate (relevant postgraduate qualification a Life sciences discipline; PharmD or other post-graduate health professional qualifications)
• At least 4 years of drug development experience, including a minimum of 3 years in drug safety/pharmacovigilance
• Experience in extracting data from the Safety Database and apply complex data analysis

If you want to learn more about this opportunity apply directly or reach out to!

*Please note that we can only consider EU/Schengen applications, or valid Swiss permit.