Associate Safety Director

OverviewJoin to apply for the Associate Safety Director role at Roche.At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.The PositionWe deliver knowledge on the safety profiles of our medicines, define how to manage risks to patients and coordinate the pharmacovigilance system activities for the company providing a safe journey for each individual patient, everywhere.ResponsibilitiesContribute to shaping the future of healthcare by providing essential safety science and pharmacovigilance support across the entire Roche portfolio, influencing both early and late-phase development activitiesServe as a key member of the safety team, offering crucial safety oversight and input into all aspects of study management from development through post-marketLead critical post-market safety activities, including signal evaluation, benefit-risk assessment, and comprehensive safety risk managementTake ownership of individual and aggregate case reporting, encompassing ICSR case management and critical aggregate reporting activities like DSUR and PBRERDrive signal detection and management, maintaining STAR and ISMP, and contributing to the strategic review of safety assessments and drug safety reportsInfluence product safety strategy and provide vital drug safety input into the overarching Clinical Development strategyContribute significantly to risk management by preparing and maintaining CCDS, labeling documents (including the IB), risk communications, RMP, and REMSAct independently with minimal supervision, demonstrating strong self-leadership, and proactively identifying and pursuing areas for personal and professional developmentQualificationsA qualified healthcare professional or Life Sciences graduate, with a preferred postgraduate qualification (e.g., PhD/MSc in Life sciences, PharmD)Possess 4 or more years of drug development experience in the pharmaceutical or related industry, with at least 2 years specifically in drug safety or a closely related fieldDemonstrate a strong understanding of GxP, regulated processes, and the end-to-end clinical trial lifecycleExhibit excellent communication skills, both written and verbal, capable of effectively collaborating with remote partners on a global teamAdept at applying complex data analysis and statistical methods to evaluate, interpret, and present scientific data with clarityPossess strong presentation skills, effective at summarizing and presenting key considerations and decision points to diverse audiencesProven ability to act independently and with minimal supervision, managing safety responsibilities on study teams and supporting safety science activitiesAbout RocheA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.Let’s build a healthier future, together.Roche is an Equal Opportunity Employer.Job DetailsSeniority level: AssociateEmployment type: Full-timeJob function: Research, Science, and EngineeringIndustries: Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment ManufacturingReferrals increase your chances of interviewing at Roche. Get notified about new Safety Director jobs in Basel, Basel, Switzerland. #J-18808-Ljbffr