The (Senior Associate) Directorwill join our motivated and expert team of physicians in the global Cardio-metabolism/Respiratory 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 Associate) Director 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. The Director may also lead a team of Safety Physicians.
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
Work in or lead cross-functional expert teams to develop or support proactive risk management strategies for assigned marketed products and/or 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 both post marketing 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
Periodic Benefit Risk Evaluation Reports / PADERs
Development Safety Update Reports
Risk Management Plans
Clinical Overview Statements
Chair the Asset Benefit Risk Team consisting of experts in Pharmacovigilance, Medical Affairs, Epidemiology and Biostatistics and other disciplines as appropriate
Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making 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
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
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
Lead strategic projects within GPV (e.g. future software solutions, strategic initiatives, addressing changing global regulatory environment)
Experience in Diabetes/Metabolism, Cardiology, or Nephrology would be an asset
Experience in clinical development would be an asset
Leadership skills required; leadership experience required for Director
Excellent interpersonal and communication skills (both written and oral) required
Sound medical-scientific and clinical knowledge and judgement required
Understanding of the pharmaceutical industry and regulatory environment required
Requirements
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
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
Compensation
This position offers a base salary typically between $183,000 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing
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