(Senior) Patient Safety Physician Oncology

工作内容

Our CompanyAt Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.Tasks & ResponsibilitiesIn this role as a ‘Associate Director / Patient Safety Physician’ for Oncology, you lead or contribute to the global Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) activities for compounds in clinical development or in the market.In More Detail, Your Tasks May Include

• Develop/ contribute to proactive patient-centric RM strategies for assigned compounds.
• Plan, manage/ perform and monitor all PV activities for assigned drugs, including:
• Set-up of safety analyses in the clinical trial and safety databases for Monitoring
• Continuous monitoring and further development of the product safety and benefit/risk profile
• Safety issue management
• In collaboration with various departments, including Clinical Development and Global Patient Engagement, development of patient-centric benefit-risk profile assessment strategies for developmental compounds.
• In collaboration with Global Epidemiology and Medical Affairs, development of safety-focused post-authorization studies
• Interpretation of clinical trial safety data for clinical trial reports and submission documents
• Review and medical-scientific input to regulatory documents (e.g. PSURs, DSURs, RMPs, Clinical Overview Statements).
• Provide updates of the assigned drug’s safety profile to senior management as requested and recommend PV/ RM activities to BI decision-making bodies.

For The Senior Position, These Would Be Additional Responsibilities

• Chair BI-internal multidisciplinary Asset Benefit Risk Team
• Represent PSPV in internal and external committees & bodies
• Contribute to the further development of PSPV within BI by staying abreast of state-of-the-art methodology, changes in the regulatory environment and developments and trends in healthcare system and society

Requirements

• Medical Doctor with clinical or research experience
• PV experience and good understanding of PV regulation in major markets
• Experience in Clinical Development and submissions for marketing authorization would be an asset
• Clinical or research experience in oncology would be a plus
• Good interpersonal and communication skills
• Strong ethical sense combined with quality and patient safety mindset
• Excellent English skills, both written and spoken

For the Senior position, you need to meet the additional requirements:

• Profound experience in PSPV and Risk Management in a pharmaceutical company on a global / corporate level, including clinical development and post-marketing safety
• Very good and broad understanding of the pharmaceutical industry, and the future trends and developments in pharmacovigilance
• Thorough understanding of PV regulation in major markets and respective need for compliance
• Project Management competencies

WHY BOEHRINGER INGELHEIM?This is where you can grow, collaborate, innovate and improve lives.We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area .Want to learn more about us? Visit https://www.boehringer-ingelheim.com/Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.READY TO CONTACT US?Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.