Senior Patient Safety Physician, CRM
Boehringer Ingelheim
full-time
Posted on:
Location Type: Office
Location: Germany
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Job Level
About the role
- Lead or contribute to integrated Patient Safety and Pharmacovigilance (PSPV) activities for compounds in clinical development or in the market.
- Designing and implementing strategies to generate appropriate safety evidence.
- Developing and contributing to proactive, patient-centric risk minimization strategies for assigned compounds.
- Planning, managing, and monitoring PV activities for assigned drugs, including setting up safety analyses in clinical trial and safety databases for monitoring.
- Continuously monitoring and further developing the product safety and benefit/risk profile.
- Managing safety signals.
- Collaborating with various departments including Clinical Development and Global Patient Engagement.
- Working with Global Epidemiology and Medical Affairs to develop safety-focused post-authorization studies.
- Interpreting clinical trial safety data for clinical trial reports and submission documents.
- Reviewing and providing medical-scientific input to regulatory documents.
Requirements
- Medical Doctor with clinical and/or clinical research experience.
- PV experience and good understanding of PV regulations in major markets.
- Experience in clinical development and submissions for marketing authorization would be an asset.
- Clinical or research experience in the field of cardio-renal-metabolism areas would be a plus.
- Strong interpersonal and communication skills.
- A strong ethical sense combined with quality and patient safety mindset.
- Excellent English skills, both written and spoken.
- For the Senior position, extensive 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, future trends and developments in pharmacovigilance.
- Thorough understanding of PV regulations in major markets and need for compliance.
- Project management and leadership competencies.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PharmacovigilanceClinical developmentSafety evidence generationRisk minimization strategiesSafety analysesProduct safety monitoringSafety signal managementClinical trial data interpretationRegulatory document review
Soft Skills
Interpersonal skillsCommunication skillsEthical senseQuality mindsetPatient safety mindsetProject managementLeadership competencies
Certifications
Medical Doctor