(Senior) Patient Safety Physician Crea

vor 3 Wochen

Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

**The Position**:
Are you passionate about patient health and safety? If yes, we have an exciting opportunity for you

Our dedicated Patient Safety teams are 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 clinical development or post-marketing drug safety. We're particularly

***Tasks & Responsibilities**:

- In this role as a (Senior) Associate Director / (Senior) Patient Safety Physician for one of our therapeutic areas, 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-authorization 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 in psychiatry or ophthalmology
- PV experience and good understanding of PV regulation in major markets
- Experience in Clinical Development and submissions for marketing authorization 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

Internal job offers are generally addressed to employees working in their current position for at least one year or working on a fixed term contract ending within one year.

For employees with a current contract of limited duration, legal / labor agreement requirements for contract extension will be considered.

***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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