(Senior) Patient Safety Physician CRM

Boehringer Ingelheim; Ingelheim am Rhein; On-site; EUR 80,000 - 100,000; Full time

Job summary

Boehringer Ingelheim is looking for experienced (Senior) Patient Safety Physicians to enhance patient health and safety. You'll work on diverse products in clinical development and safety, especially in cardiovascular, renal, hepatic, and metabolic diseases. This role requires a Medical Doctor with clinical experience and strong communication skills, emphasizing patient safety and ethical standards.

The position involves developing proactive risk minimization strategies and interpreting safety data for regulatory submissions.

Qualifications

• Medical Doctor with clinical and/or clinical research experience.
• PV experience and good understanding of PV regulations.
• Experience in clinical development and submissions for marketing authorization is an asset.

Responsibilities

• Designing and implementing strategies to generate appropriate safety evidence.
• Developing patient-centric risk minimization strategies.
• Monitoring PV activities for assigned drugs.

Skills

Clinical research experience

Strong interpersonal skills

Ethical sense

Excellent English skills

Education

Medical Doctor

Job description

The Position

Are you a Medical Doctor who is passionate about patient health and safety? If yes, we have an exciting opportunity for you!

Our dedicated TA CRM Team is seeking experienced (Senior) Patient Safety Physicians to join us on our journey. You'll have the chance to work on a variety of products, either in late-stage clinical development or post-marketing drug safety. We're particularly interested in physicians with expertise in cardiovascular, renal, hepatic, and/or metabolic diseases.

Tasks & Responsibilities

• 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, to develop patient-centric benefit-risk profile assessment strategies for developmental compounds
• 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 (e.g., IBs, PSURs, DSURs, RMPs, Clinical Overview Statements)
• Updating senior management on the assigned drug’s safety profile and recommending PV/RM activities to BI decision‑making committees

Additional Responsibilities (Senior Position)

• Chairing Boehringer Ingelheim internal multidisciplinary Asset Benefit Risk Teams
• Representing PSPV in internal and external committees
• Contributing to the further development of PSPV within BI by staying abreast of state‑of‑the‑art methodology and technology, changes in the regulatory environment, and developments and trends in the healthcare system and society

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

Additional Requirements (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
• A very good and broad understanding of the pharmaceutical industry, as well as future trends and developments in pharmacovigilance
• Thorough understanding of PV regulations in major markets and the respective need for compliance
• Project management and leadership competencies