Associate Safety Director

Turn safety data into smarter decisions that protect patients worldwide.

Proclinical is seeking an Associate Safety Director to join a dynamic team in Switzerland. This role focuses on providing safety science and pharmacovigilance expertise across the drug development lifecycle, from early-phase studies to post-market activities. You will play a key role in ensuring the safety of assigned products, contributing to regulatory submissions, and managing risk strategies.

This position offers a hybrid work model following an initial training period.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Develop and maintain a deep understanding of the safety profile of assigned products or therapy areas.
• Oversee individual and aggregate case reporting activities, including ICSR case management, medical review, and DSUR/PBRER reporting.
• Conduct signal detection and management, contributing to safety assessments and reports for regulatory authorities.
• Lead risk management activities, including CCDS preparation, labeling updates, and RMP maintenance.
• Review clinical protocols, study reports, Investigator Brochures (IB), and informed consent forms (ICF) to ensure alignment with safety strategies.
• Contribute to regulatory submissions such as INDs, NDAs, MAAs, and variations.
• Prepare and maintain safety sections of the Company Core Data Sheet and Reference Safety Information.
• Participate in Drug Monitoring Committees (DMC) or internal monitoring committees (IMC) as needed.
• Present safety issues to internal and external governance committees.
• Collaborate with vendors and global partners to support safety science activities.
• Apply complex data analysis and statistical methods to interpret and present scientific data effectively.
• Support process improvement initiatives and cross-functional teamwork.

Key Skills and Requirements:

• Qualified healthcare professional or life sciences graduate; advanced qualifications (e.g., PhD, MSc, PharmD) are advantageous.
• Minimum of 4 years of drug development experience, with at least 3 years in drug safety/pharmacovigilance.
• Proficiency in Excel, Word, PowerPoint, and safety databases, with the ability to perform complex data analysis.
• Fluent in English, both written and verbal.
• Strong communication and presentation skills, with the ability to summarize and present key considerations effectively.
• Familiarity with GxP standards and the clinical trial lifecycle.
• Experience working in global, cross-functional teams.