Associate Safety Director

Darum lohnt es sich

ppTurn safety data into smarter decisions that protect patients worldwide. /p pProclinical is seeking an Associate Safety Director to join a dynamic team in Switzerland.

You will play a key role in ensuring the safety of assigned products, contributing to regulatory submissions, and managing risk strategies. /p pThis position offers a hybrid work model following an initial training period. /p pPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /p h3Responsibilities /h3 ul liDevelop and maintain a deep understanding of the safety profile of assigned products or therapy areas. /li liOversee individual and aggregate case reporting activities, including ICSR case management, medical review, and DSUR/PBRER reporting. /li liConduct signal detection and management, contributing to safety assessments and reports for regulatory authorities. /li liLead risk management activities, including CCDS preparation, labeling updates, and RMP maintenance. /li liReview clinical protocols, study reports, Investigator Brochures (IB), and informed consent forms (ICF) to ensure alignment with safety strategies. /li liContribute to regulatory submissions such as INDs, NDAs, MAAs, and variations. /li liPrepare and maintain safety sections of the Company Core Data Sheet and Reference Safety Information. /li liParticipate in Drug Monitoring Committees (DMC) or internal monitoring committees (IMC) as needed. /li liPresent safety issues to internal and external governance committees. /li liCollaborate with vendors and global partners to support safety science activities. /li liApply complex data analysis and statistical methods to interpret and present scientific data effectively. /li liSupport process improvement initiatives and cross-functional teamwork. /li /ul h3Key Skills and Requirements /h3 ul liQualified healthcare professional or life sciences graduate; advanced qualifications (e.g., PhD, MSc, PharmD) are advantageous. /li liMinimum of 4 years of drug development experience, with at least 3 years in drug safety/pharmacovigilance. /li liProficiency in Excel, Word, PowerPoint, and safety databases, with the ability to perform complex data analysis. /li liFluent in English, both written and verbal. /li liStrong communication and presentation skills, with the ability to summarize and present key considerations effectively. /li liFamiliarity with GxP standards and the clinical trial lifecycle. /li liExperience working in global, cross-functional teams. /li /ul pBy submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data. /p /p This role focuses on providing safety science and pharmacovigilance expertise across the drug development lifecycle, from early-phase studies to post-market activities.