Safety Director
Vor 3 Tagen
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
Safety Director
We 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
The opportunity:
• Safety Strategy Management: You will define and implement safety strategies while collaborating with cross-functional teams and integrating safety considerations into drug development and lifecycle management.
• Pharmacovigilance Oversight and Compliance: You will lead end-to-end pharmacovigilance processes, ensure global regulatory compliance, and support key safety document submissions.
• Signal Management and Benefit-Risk Evaluation: You will oversee signal detection activities, perform benefit-risk evaluations, and ensure timely escalation and resolution of safety concerns.
• Risk and Business Continuity Management: You will develop and maintain Risk Management Plans (RMPs), support robust Business Continuity Planning (BCP) strategies, and ensure preparedness for unforeseen disruptions.
• Stakeholder Engagement and Global Collaboration: You will engage with internal and external stakeholders to align safety strategies and objectives, facilitating a transparent and proactive approach to addressing safety concerns.
• Business Process Optimization: You will oversee outsourced processes, drive process improvements, and enhance service delivery while ensuring alignment with regulatory requirements and organizational goals.
Who You Are:
• You have a strong background in pharmacovigilance and safety strategy management.
• You excel in cross-functional collaboration and bring a proactive approach to team engagement.
• You possess in-depth knowledge of global regulatory requirements including GVP, ICH, FDA, and EMA.
• You have expertise in risk management and business continuity planning, ensuring preparedness for unforeseen disruptions.
• You effectively engage with internal and external stakeholders, fostering transparency and alignment in safety strategies.
• You drive process improvements and oversee outsourced functions to ensure seamless integration with core business operations.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
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