Senior Associate Director/Associate Director, Medical Safety
US-BI Pharma/BI USA
 Ridgefield, CT

Candidate will be hired at level commensurate with experience and education

Senior Associate Director, Medical Safety

Description:

Senior Associate Director has responsibility for the pharmacovigilance risk management activities of KEY* marketed and/or investigational compounds on a global level and/or responsibility for the pharmacovigilance risk management activities for other important marketed and/or investigational compounds on a global level. In additional to reporting to US line management, this position matrix reports into a Head Risk Management TA X, Global Pharmacovigilance and additionally may matrix report into a Lead Risk Management Physician.

*as defined by GPV Management Board

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 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 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 Report / PADERs
      • Development Safety Update Reports
      • Risk Management Plans
      • Clinical Overview Statements
  • May chair the BI-internal Pharmacovigilance Working Group 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 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

Requirements:

  • US MD or DO degree, from an accredited institution, or international equivalent
  • 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
    • At least one (1) to two (2) years of clinical experience, beyond residency
  • International business experience
  • Pharmaceutical/Biotech/CRO industry experience (preferably some experience in Pharmacovigilance and Risk Management) or equivalent experience in academia or government
  • Total applicable experience (clinical plus industry) >2 years
  • Ability to lead projects and influence teams
  • Excellent interpersonal and communication skills (both written and oral)
  • Very good and broad understanding of the pharmaceutical industry, and the future trends and developments in pharmacovigilance
  • Thorough understanding of pharmacovigilance regulation in major markets and respective need for compliance

Associate Director, Medical Safety:

Description:

Associate Director has responsibility for the pharmacovigilance risk management activities for marketed compounds on global level and/or contributes to the pharmacovigilance risk management activities of key or core strategic* marketed and/or investigational compounds on global level. In additional to reporting to US line management, this position matrix reports into a Head Risk Management TA X, Global Pharmacovigilance and additionally may matrix report into a Lead Risk Management Physician.

*as defined by GPV Management Board

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 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
  • Provide updates of the assigned drug’s safety profile to senior management as requested and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU QPPV

Requirements:

  • US MD or DO degree, from an accredited instituion, or international equivalent
  • 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
    • At least one (1) to two (2) years of clinical experience, beyond residency
  • Leadership potential
  • Excellent interpersonal and communication skills (both written and oral)
  • Good understanding of the pharmaceutical industry, and the future trends and developments in pharmacovigilance
  • 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)
  • Board certification / experience in cardiology, metabolic disease management, hepatology, pulmonology, oncology, or biosimilars would be an asset

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, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA Inc., Boehringer Ingelheim Animal Health Puerto Rico LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; citizenship status, marital, domestic partnership or civil union status; gender, gender identity or expression; affectional or sexual orientation; pregnancy, childbirth or related medical condition; physical or psychiatric disability; veteran or military status; domestic violence victim status; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by applicable federal, state or local law.

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