Director/Senior Associate Director/Associate Director, Medical Safety, Therapeutic Area Cardio-metabolism

Employment Type

:

Industry

: Miscellaneous



Description:

We at Boehringer Ingelheim (BI) Medicine share one vision\: to turn patient-focused innovations into life-changing treatments. We focus on driving medical innovation, combining scientific and patient insights to develop and deliver safe and effective solutions. By concentrating on first-in-class innovations, we aim to set new standards for patient care now and for years to come.  

The Associate Director/Sr. Associate Director/Director, Medical Safety will join our motivated and expert team of physicians in the Global Patient Safety and Pharmacovigilance (GPV) department at BI, whose priority is the wellbeing of our patients worldwide.  This is a highly visible role for an individual 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.  

Description\:

Responsible for pharmacovigilance risk management activities of marketed and/or investigational compounds in the Cardio-Metabolism Therapeutic Area on global level.  This may include a portfolio of products/investigational compounds within an assigned disease area. In addition to reporting to US line management, this position may matrix report to a Lead Risk Management Physician or Risk Management Therapeutic Area Head.

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.


***Candidate will be hired at level commensurate with experience and education

Director, Medical Safety
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
•    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 drug’s 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.
•    Total applicable experience (incl. clinical practice, research or relevant industry) of greater than five (>5) years, and a minimum of two (2) years of experience in the pharmaceutical industry or equivalent (preferably pharmacovigilance) required.
•    One to three (1-3) years of leadership experience (e.g. projects, teams, initiative) and influencing teams required.
•    Potential for people leadership.
•    Strong leadership skills and executive presence.
•    People leadership experience preferred.
•    International experience / international exposure in daily business preferred.
•    Board certification/experience in a medicine sub-specialty preferred.
•    Excellent interpersonal and communication skills (both written and oral).
•    Ability to attend key meetings in person.
•    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.
•    Thorough 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.
•    This role is accountable for proactive risk management of assigned key marketed and/or investigational compound or a product family including continuous assessment of the benefit-risk profile and performing risk minimization as required to ensure safe use in patients.
•    Thorough understanding of Pharmacovigilance regulation in major markets and respective need for compliance.


Desired Skills, Experience and Abilities\:
•    At least one (1) to two (2) years of clinical experience beyond residency preferred
•    Board certification/experience in cardiology, metabolic disease, or hepatology preferred
•    Experience in Clinical Development/ submissions for marketing authorization preferred

Senior Associate Director, Medical Safety

Duties & Responsibilities\:
•    Develop or support proactive risk management strategies for assigned key marketed 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 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
•    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 lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound or product 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 and the EU QPPV.
•    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 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.
•    May represent GPV 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 medicine subspecialty preferred.
•    People leadership potential.
•    Total applicable experience (incl. clinical practice, plus research or relevant industry) of greater than three (>3) years required.
•    Strong leadership skills incl. the ability to lead projects and influence teams.
•    Excellent interpersonal and communication skills (both written and oral).
•    Ability to attend key meetings in person.
•    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.

Desired Skills, Experience and Abilities\:
•    Pharmaceutical/Biotech/CRO industry experience (at least 1-2 years) (preferably some experience in Pharmacovigilance and Risk Management) preferred
•    At least one (1) to two (2) years of clinical experience beyond residency preferred 
•    Board certification / experience in cardiology, metabolic disease management, or hepatology preferred 
•    Experience in Clinical Development/ submissions for marketing authorization preferred

Associate Director, Medical Safety
Duties & Responsibilities\:

•    Develop or support proactive risk management strategies for assigned marketed compounds. Support development of risk management strategies for 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 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

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.
•    Total applicable experience (incl. clinical practice, research or relevant industry) of greater than two (>2) years.
•    Board certification / experience in a medicine subspecialty preferred.
•    Leadership potential required.
•    Excellent interpersonal and communication skills (both written and oral).
•    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.
•    Desire for increasing professional growth.
•    Sound medical-scientific and clinical knowledge and judgement.
•    Ability to synthesize large amounts of medical data and draw medical conclusions.
•    Understanding of the pharmaceutical industry and regulatory environment.


Desired Skills, Experience and Abilities\:
•    At least one (1) to two (2) years of clinical experience, beyond residency
•    Pharmaceutical/Biotech/CRO industry experience (at least 1-2 years) (preferably some experience in Pharmacovigilance and Risk Management) preferred
•    Board certification / experience in cardiology, metabolic disease management, or hepatology preferred 
•    Experience in Clinical Development/ submissions for marketing authorization preferred

Eligibility Requirements\: 
•    Must be legally authorized to work in the United States without restriction.
•    Must be willing to take a drug test and post-offer physical (if required).
•    Must be 18 years of age or older.

Who We Are\:

At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.

Want to learn more?  Visit boehringer-ingelheim.com and join us in our effort to make more health.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race; 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.

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