Associate Safety Director

CTC Resourcing Solutions AG in Basel, CH, seeks an Associate Safety Director for an on-site contract role. The position requires expertise in drug safety, GxP standards, and clinical trial lifecycle, with responsibilities including safety data analysis, regulatory reporting, and risk management.

This role focuses on building and maintaining in-depth knowledge of product safety profiles, disease contexts, competitor safety data, and mechanisms of action to support drug development and regulatory compliance.

Responsibilities

• Build and maintain expert knowledge on product safety profiles, disease contexts, competitor safety data, and mechanisms of action.
• Lead medical reviews of individual case safety reports (ICSR) and aggregate safety reports (DSUR, PBRER), including responses to regulatory questions.
• Manage signal detection, assessment, and mitigation, including developing safety evaluation strategies and drug safety reports.
• Independently oversee risk management tasks such as creating and updating the Company Core Data Sheet, labeling documents, risk communications, and Risk Management Plans.
• Review clinical trial materials (protocols, study reports, Investigator’s Brochure, ICF) to ensure alignment with safety and risk management goals.
• Provide safety science input to regulatory submissions.
• Participate in Drug Monitoring Committees (iDMC) and internal monitoring committees, contributing expert insights.
• Take on specialized roles within the department, such as functional business process owner, subject matter expert, or safety committee member.
• Coordinate with external vendors supporting Safety Science functions.
• Apply GxP standards, improve processes, and use complex data analysis to interpret and present safety findings.

Requirements

• Must hold a Swiss working/residency permit or be a Swiss/EU citizen.
• Must be a qualified healthcare professional or hold a Life Sciences degree.
• Proven experience at the Associate Safety Director level with GxP and clinical trial lifecycle expertise.
• Minimum of 4 years of experience in drug development within the pharmaceutical or related industry.
• Minimum of 3 years in drug safety (PV) or a closely related field.
• Ability to extract data from the Safety Database and perform complex data analysis.
• Strong communication skills and fluency in English, both written and spoken.

Nice to have

• A postgraduate qualification in a Life Sciences discipline (e.g., PhD, MSc) or a health professional qualification (e.g., PharmD) is advantageous.