Director/Senior Associate Director, Medical Safety Physician - CRM (Remote) - Boehringer Ingelheim
Ridgefield, CT
About the Job
Description
The (Senior Associate) Director will 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. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)
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.
The (Senior Associate) Director will 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. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)
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.
Source : Boehringer Ingelheim
