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(Senior) Patient Safety Physician CRM(m/w/x)
Designing safety strategies and managing pharmacovigilance for drugs in cardio-renal-metabolism, analyzing clinical trial data. Medical Doctor with PV experience and regulatory understanding required. Focus on innovative therapies in early clinical development.
Requirements
- Medical Doctor with clinical or clinical research experience
- PV experience and good understanding of PV regulations in major markets
- Experience in clinical development and submissions for marketing authorization
- Clinical or research experience in cardio-renal-metabolism areas
- Strong interpersonal and communication skills
- Strong ethical sense and quality and patient safety mindset
- Excellent English skills, both written and spoken
- Extensive experience in PSPV and Risk Management in a pharmaceutical company
- Very good understanding of the pharmaceutical industry and future trends in pharmacovigilance
- Thorough understanding of PV regulations in major markets and compliance needs
- Project management and leadership competencies
Tasks
- Design and implement safety evidence strategies
- Develop patient-centric risk minimization strategies
- Plan and manage pharmacovigilance activities for assigned drugs
- Set up safety analyses in clinical trial databases
- Continuously monitor and develop product safety profiles
- Manage safety signals effectively
- Collaborate with Clinical Development and Global Patient Engagement
- Work with Global Epidemiology and Medical Affairs on post-authorization studies
- Interpret clinical trial safety data for reports and submissions
- Review and provide input on regulatory documents
- Update senior management on drug safety profiles
- Recommend pharmacovigilance activities to decision-making committees
- Chair internal multidisciplinary Asset Benefit Risk Teams (Senior position)
- Represent Patient Safety and Pharmacovigilance in committees (Senior position)
- Contribute to the development of Patient Safety and Pharmacovigilance methodologies (Senior position)
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
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(Senior) Patient Safety Physician CRM(m/w/x)
Designing safety strategies and managing pharmacovigilance for drugs in cardio-renal-metabolism, analyzing clinical trial data. Medical Doctor with PV experience and regulatory understanding required. Focus on innovative therapies in early clinical development.
Requirements
- Medical Doctor with clinical or clinical research experience
- PV experience and good understanding of PV regulations in major markets
- Experience in clinical development and submissions for marketing authorization
- Clinical or research experience in cardio-renal-metabolism areas
- Strong interpersonal and communication skills
- Strong ethical sense and quality and patient safety mindset
- Excellent English skills, both written and spoken
- Extensive experience in PSPV and Risk Management in a pharmaceutical company
- Very good understanding of the pharmaceutical industry and future trends in pharmacovigilance
- Thorough understanding of PV regulations in major markets and compliance needs
- Project management and leadership competencies
Tasks
- Design and implement safety evidence strategies
- Develop patient-centric risk minimization strategies
- Plan and manage pharmacovigilance activities for assigned drugs
- Set up safety analyses in clinical trial databases
- Continuously monitor and develop product safety profiles
- Manage safety signals effectively
- Collaborate with Clinical Development and Global Patient Engagement
- Work with Global Epidemiology and Medical Affairs on post-authorization studies
- Interpret clinical trial safety data for reports and submissions
- Review and provide input on regulatory documents
- Update senior management on drug safety profiles
- Recommend pharmacovigilance activities to decision-making committees
- Chair internal multidisciplinary Asset Benefit Risk Teams (Senior position)
- Represent Patient Safety and Pharmacovigilance in committees (Senior position)
- Contribute to the development of Patient Safety and Pharmacovigilance methodologies (Senior position)
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
About the Company
Boehringer Ingelheim
Industry
Healthcare
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
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