(Senior) Patient Safety Physician Inflammation
vor 5 Monaten
**The Position**:
Are you passionate about patient health and safety? If yes, we have an exciting opportunity for you
**Tasks & Responsibilities**:
- In this role as a (Senior) Associate Director / (Senior) Patient Safety Physician for Inflammation, you will 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
- Collaborate with various departments, including Clinical Development and Global Patient Engagement, to develop patient-centric benefit-risk profile assessment strategies for developmental compounds.
- Work with Global Epidemiology and Medical Affairs to develop safety-focused post-authorisation studies.
- Interpret clinical trial safety data for clinical trial reports and submission documents
- Review and provide medical-scientific input to regulatory documents (e.g. PSURs, DSURs, RMPs, Clinical Overview Statements).
- Update senior management on the assigned drug’s safety profile 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 and/or clinical research experience
- PV experience and good understanding of PV regulation in major markets
- Experience in Clinical Development and submissions for marketing authorisation would be an asset
- Clinical or research experience in one or more of the above disease areas 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
***Ready to contact us?**:
Recruiting Process
Step 2: Virtual meeting in the period from End of May
Step 3: On-site interviews beginning of End of May until End of June
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