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BOBoehringer Ingelheim

(Senior) Patient Safety Physician CRM(m/w/x)

Ingelheim am Rhein
Full-timeOn-siteSenior

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

  • EnglishBusiness Fluent
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