Senior Patient Safety Physician - Inflammation

The Senior Patient Safety Physician - Inflammation has responsibility for the pharmacovigilance risk management activities of investigational compounds on a global level.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the company's success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

• Develop or support proactive risk management strategies for assigned investigational compounds.
• Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
  • Continuous monitoring and further development of the product safety profile
  • Safety issue management
  • Set-up of safety analyses in clinical trial database
  • Close collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and Epidemiologic studies
  • Review and medical-scientific input to regulatory documents such as
    • Development Safety Update Reports
    • Clinical Overview Statements
• Depending on the status of development of the compound, may be required to lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound including project-specific training and coaching of team members, review of team output.
• Provide updates of the assigned drug´s safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies.
• Represent Global Pharmacovigilance in internal and external committees & bodies.
• Contribute to the further development of pharmacovigilance 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
• Contribute to strategic projects within Experimental Medicine (e.g. future software solutions, strategic initiatives, addressing changing global regulatory environment).
• Represent Patient Safety during global health authority interactions.

Requirements

• US MD or DO degree or international equivalent from an accredited institution required.
• In addition, the following are strongly preferred:
  • Completion of a US residency or ex-US equivalent.
  • Active or inactive US license to practice medicine, or international equivalent.
• Board certification / experience in a related specialty would be an asset
• People leadership potential required.
• Total applicable experience (incl. clinical practice, plus research or relevant industry) of greater than three years required.
• Strong leadership skills incl. the ability to lead projects and influence teams required.
• Excellent interpersonal and communication skills (both written and oral) required.
• Ability to attend key meetings in person required.
• Highly ethical personality putting patient safety first.
• Self-starter and driving personality, willingness to take on responsibilities.
• Sound medical-scientific and clinical knowledge and judgement.
• Ability to synthesize large amounts of medical data, draw medical conclusions, and clearly communicate the conclusions.
• Good understanding (based on experience) of Pharmacovigilance and Risk Management in a major pharmaceutical company on a global / corporate level, including safety in clinical development and post-marketing safety.
• Understanding of pharmacovigilance regulation in major markets and respective need for compliance.

Compensation Data