Key Responsibilities
Contribute to shaping the future of healthcare by providing essential clinical safety and pharmacovigilance support across the entire Roche portfolio Serve as a key member of the safety team, offering crucial safety oversight and input into all aspects of study management from development through post‑market Lead critical post‑market safety activities, including signal evaluation, benefit‑risk assessment, and comprehensive safety risk management Take ownership of individual and aggregate case reporting, encompassing ICSR case management and critical aggregate reporting activities like DSUR and PBRER Drive signal detection and management, contribute to the strategic review of safety assessments and drug safety reports Influence product safety strategy and provide vital safety input into the overarching Clinical Development strategy Contribute significantly to risk management by preparing and maintaining CCDS, labeling documents (including the IB), risk communications, RMP, and REMS Act independently with minimal supervision, demonstrating strong self‑leadership, and proactively identifying and pursuing areas for personal and professional development Qualifications
A relevant post‑graduate qualification PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post‑graduate health professional qualifications would be advantageous Demonstrate a strong understanding of GxP, regulated processes, and the end‑to‑end clinical trial lifecycle Exhibit excellent communication skills, both written and verbal, capable of effectively collaborating with remote partners on a global team Adept at applying complex data analysis and statistical methods to evaluate, interpret, and present scientific data with clarity Possess strong presentation skills, effective at summarizing and presenting key considerations and decision points to diverse audiences Proven ability to act independently and with minimal supervision, managing safety responsibilities on study teams and supporting clinical safety activities Hard Skills
pharmacovigilance signal evaluation benefit‑risk assessment ICSR case management aggregate reporting data analysis statistical methods clinical trial lifecycle risk management safety risk management Soft Skills
communication skills self‑leadership collaboration presentation skills independence proactive identification professional development
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Contribute to shaping the future of healthcare by providing essential clinical safety and pharmacovigilance support across the entire Roche portfolio Serve as a key member of the safety team, offering crucial safety oversight and input into all aspects of study management from development through post‑market Lead critical post‑market safety activities, including signal evaluation, benefit‑risk assessment, and comprehensive safety risk management Take ownership of individual and aggregate case reporting, encompassing ICSR case management and critical aggregate reporting activities like DSUR and PBRER Drive signal detection and management, contribute to the strategic review of safety assessments and drug safety reports Influence product safety strategy and provide vital safety input into the overarching Clinical Development strategy Contribute significantly to risk management by preparing and maintaining CCDS, labeling documents (including the IB), risk communications, RMP, and REMS Act independently with minimal supervision, demonstrating strong self‑leadership, and proactively identifying and pursuing areas for personal and professional development Qualifications
A relevant post‑graduate qualification PHD/MSc in a Life sciences discipline; Medical qualification; PharmD or other post‑graduate health professional qualifications would be advantageous Demonstrate a strong understanding of GxP, regulated processes, and the end‑to‑end clinical trial lifecycle Exhibit excellent communication skills, both written and verbal, capable of effectively collaborating with remote partners on a global team Adept at applying complex data analysis and statistical methods to evaluate, interpret, and present scientific data with clarity Possess strong presentation skills, effective at summarizing and presenting key considerations and decision points to diverse audiences Proven ability to act independently and with minimal supervision, managing safety responsibilities on study teams and supporting clinical safety activities Hard Skills
pharmacovigilance signal evaluation benefit‑risk assessment ICSR case management aggregate reporting data analysis statistical methods clinical trial lifecycle risk management safety risk management Soft Skills
communication skills self‑leadership collaboration presentation skills independence proactive identification professional development
#J-18808-Ljbffr
Associate Safety Director – Senior Safety Scientist Arbeitgeber: Jobtailor
Als Global Director B2B – Business Development bei uns profitieren Sie von einer dynamischen und innovativen Arbeitsumgebung, die auf Zusammenarbeit und Kreativität setzt. Wir bieten Ihnen nicht nur attraktive Vergütungsmodelle und umfassende Weiterbildungsmöglichkeiten, sondern auch die Chance, in einem internationalen Team zu arbeiten, das Vielfalt und persönliche Entwicklung fördert. Unsere Unternehmenskultur legt großen Wert auf Flexibilität und Work-Life-Balance, sodass Sie Ihre Karriereziele in einem unterstützenden Umfeld erreichen können.
