Description
The (Senior) Patient Safety Physicianwill join our motivated and expert team of physicians in the global Inflammation Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. This is a highly visible role for an individual with a strong medical/scientific background who is inspired by prioritizing patient safety and who will help BI develop its growing portfolio of innovative medicines. BI believes that our people are our strongest asset - this role will provide you with the opportunity for significant professional development. The (Senior) Patient Safety Physician is a key member of global, cross functional product teams that determine the medical-scientific strategy for the respective products. This role is accountable for proactive risk management of assigned marketed and/or investigational compound or a product family on a global level; this includes continuous assessment of the benefit-risk profile and performing risk minimization as required to ensure safe use in patients.
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 companies' 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, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities
- Develop proactive risk management strategies for assigned marketed and/or investigational compounds
- Set and align standards across products/compounds within the assigned portfolio.
- Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities. Oversee and ensure implementation of such activities across assigned portfolio, including:
- Continuous monitoring and further development of the product safety profile
- Safety issue management
- Set-up of safety analyses in both postmarketing and clinical trial databases
- 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
- Safety components of submission documents for global marketing authorization
- Periodic Benefit Risk Evaluation Reports / PADERs
- Development Safety Update Reports
- Risk Management Plans
- Clinical Overview Statements
- c o Chair the BI-internal Pharmacovigilance Working Group consisting of experts in Pharmacovigilance, Medical Affairs, Epidemiology and Biostatistics and other disciplines as appropriate
- Depending on the status of development of the compound, may be required to strategically lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound, product or portfolio compound/product or project including project management, project-specific training and coaching of team members, review of team output
- Provide updates or coach direct reports to provide updates of the assigned drugs safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU QPPV
- Represent Global Pharmacovigilance in internal and external committees & bodies. This may include high profile committees such as FDA advisory committees, global regulatory authority meetings, Advisory Boards, Board of Managing Directors, congresses.
- 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.
- Lead strategic projects within GPV (e.g. future software solutions, strategic initiatives, addressing changing global regulatory environment).
- In addition to global responsibilities, may represent PV at US-specific cross-functional meetings that require Risk Management support such as MAT, TASC. May serve as liaison from team to VP, GPV-US and provide regular updates to US teams and leadership as needed.
- Contribute to strategic planning regarding US Risk Management topics. May act as designee/substitute for VP, GPV-US or Global Risk Management Therapeutic Area Head at US meetings.
Requirements
- US MD or DO degree or international equivalent from an accredited institution.
- 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.
Candidate will be hired at level commensurate with experience and education.
Associate Director Requirements:
- US MD or DO degree or international equivalent from an accredited institution and more than 2 years of applicable experience, required.
Sr. Associate Director Requirements:
- US MD or DO degree or international equivalent from an accredited institution and more than 3 years of applicable experience, required.
Director Requirements:
- US MD or DO degree or international equivalent from an accredited institution and more than 5 years of applicable experience, required.
- Minimum of 2 years of experience in the pharmaceutical industry or pharmacovigilance required.
- Leadership experience required.
Compensation
This position offers a base salary typically between $163,000 and $350,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.