Associate Safety Director (7008)
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Quelle: StudySmarter Stellenbestand · Status: aktiv · Bewerbung über das zentrale StudySmarter-Formular.
Die ganze Ausschreibung von CTC Resourcing Solutions
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Das ist der Job
The job requires on-site presence in Basel (Switzerland), and the initial contract duration is 12 months.
Darum lohnt es sich
CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.
Our client, a Swiss multinational healthcare company headquartered in Basel, is looking for a: Associate Safety Director with at least 4 years of drug development experience, including a minimum of 3 years in drug safety/pharmacovigilance.
Your Main Responsibilities Develop and maintain expert knowledge of product safety profiles, disease contexts, competitor safety data, and mechanisms of action Lead medical reviews for individual case safety reports (ICSR) and aggregate reporting (DSUR, PBRER), including responses to regulatory inquiries Drive signal detection, assessment, and management, including strategy development for safety evaluations and drug safety reports Independently own risk management activities: develop and maintain 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 strategies and risk management approaches Contribute safety science expertise to regulatory submissions Participate in and provide input to Drug Monitoring Committees (iDMC) and internal monitoring committees Assume specialized roles within the department, such as functional business process owner, subject matter expert, or safety committee member Coordinate and collaborate with external vendors supporting Safety Science functions Apply GxP standards, drive process improvements, and leverage complex data analysis to interpret and present safety findings Your Profile Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required Qualified healthcare professional or Life Sciences graduate.
Preferred Qualifications: A relevant postgraduate qualification would be advantageous (e.g.
PHD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications) Associate Safety Director level and proven track record GxP & clinical trial lifecycle expertise At least 4 years of experience in drug development in the pharmaceutical or related industry At least 3 years in drug safety/PV or a closely related field IT/Tool Skills: able to extract data from the Safety Database and apply complex data analysis, and strong presentation skills Excellent communication skills and fluency in English, written and spoken NOTE: Only profiles with the required education and seniority will be considered.
Thank you for your understanding. #J-18808-Ljbffr
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