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 interested in physicians with expertise in Oncology. If you're ready to take on this challenge and make a real difference in patient safety, we look forward to receiving your application!

Tasks Responsibilities

In this role as a (Senior) Associate Director / (Senior) Patient Safety Physician for Oncology, 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. IBs, 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

PV experience in Clinical Development and submissions for marketing authorizsation would be an asset

Clinical or clinical research experience in Oncology

Good interpersonal and communication skills

Strong ethical sense combined with quality and patient safety mindset

Excellent English skills, both written and spoken

Ability to handle ambiguity and present complex situations clearly to generate implementation solutions

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 and leadership competencies

Board certification in Internal Medicine and/or Medical Oncology would be a plus

*Ready to contact us? *

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or per mail: [email protected]

Please submit your application documents in English.

Recruiting Process:

Step 1: Online application - application deadline is End of June 2024

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

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.