Associate Director – Drug Safety

OverviewAssociate Director – Drug Safety – 6700Our client is a leading Swiss multinational healthcare company headquartered in Basel, Switzerland. Operating in Pharmaceuticals and Diagnostics, it is one of the world’s largest biotech companies and a global leader in in-vitro diagnostics and cancer treatments. Our client is known for its strong focus on innovation, particularly in personalized healthcare, and has played a major role in developing treatments for oncology, immunology, infectious diseases, and neuroscience.This is a contract role for a duration of 12 months to be based in Basel. During the first three months full office presence would be appreciated for training purposes after which it can go Hybrid.A perfect candidate for this role is someone with at least 4 years of drug development experience, including a minimum of 3 years in drug safety/pharmacovigilance, and is a qualified healthcare or life sciences professional. This individual must possess the expert understanding required to proactively manage all aspects of product safety, including signal detection, risk management (RMP/CCDS), and complex data analysis, while ensuring all documentation and regulatory submissions adhere to GxP standards.Main ResponsibilitiesResponsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER).Responsible for 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.Take responsibility for safety science contributions to regulatory authority submissions (Investigational New Drug/IND applications, New Drug Applications/NDAs, Marketing Authorization Applications/MAAs, Variations, Renewals, etc.).Responsible for the preparation and maintenance of safety sections of the Company Core Data Sheet and/or Reference Safety Information in the IB.Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable.In partnership with the SSL, support presentation of important safety issues to the Drug Safety Committee (DSC), Development Review. Committee (DRC) and other internal and external review and governance committees as needed.Acts independently to manage safety responsibilities on study teams and in activities supporting clinical safety.Take on the responsibility for specialised roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert.May be expected to support non-molecule projects, due diligence evaluations and other projects as needed.Perform specialized roles with PCS. These may include, but are not limited to; functional business process owner, subject matter expert, safety committee member.Responsible for coordination and collaboration with vendors servicing Safety Science.Understanding of GxP and regulated processes and end to end clinical trial lifecycle.Strong orientation towards process improvement and cross-functional teamwork.Effectively work with remote partners on a global team.Excellent communication skills, both written and verbal.Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity.Strong presentation skills, effective at summarizing and presenting the key considerations and decision points.Qualifications and ExperienceRelevant Swiss working/residency permit or Swiss/EU-Citizenship requiredPreferred Qualifications: A relevant postgraduate qualification e.g. PhD/MSc in a Life sciences discipline; PharmD or other post-graduate health professional qualifications4 or more years of drug development experience in the pharmaceutical or related industryAt least 3 years in drug safety/PV or a closely related field.IT/Tool Skills good Excel/Word/PowerPoint skills; able to extract data from the Safety Database and apply complex data analysisFluent in English, both written and verbalWould you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone. #J-18808-Ljbffr