Senior Associate Director

1 month ago

Ridgefield, United States BioCT Innovation Commons Full time

The Director has responsibility for pharmacovigilance risk management activities of marketed and/or investigational compounds on a global level. This may include a portfolio of products/investigational compounds within an assigned disease area or TA. In addition to reporting to US line management, this position may matrix report into a Head Risk Management TA X, Global Pharmacovigilance.

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.
      • Co-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 medically 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 required.
  • Strong leadership skills and executive presence required.
  • People leadership experience preferred.
  • International experience / international exposure in daily business preferred.
  • Board certification/experience in a medicine sub-specialty would be an asset.
  • Excellent interpersonal and communication skills (both written and oral) required.
  • 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.
  • 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.
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.

#J-18808-Ljbffr

  • LPN - Licensed Practical Nurse - Full Time

    1 month ago

    Ridgefield, United States Benchmark Senior Living Full time

    Join, stay, and grow with Benchmark. Connect with your calling. Benchmark Senior Living invites you to explore career opportunities that embrace your talents and aspirations! At Benchmark, we are dedicated to providing exceptional care and support to our senior residents. We are currently seeking compassionate Licensed Practical Nurses (LPN) with a genuine...

  • LPN - Licensed Practical Nurse - Full Time

    3 days ago

    Ridgefield, United States Benchmark Senior Living Full time

    Job Description: Join, stay, and grow with Benchmark. Connect with your calling.Benchmark Senior Living invites you to explore career opportunities that embrace your talents and aspirations! At Benchmark, we are dedicated to providing exceptional care and support to our senior residents. We are currently seeking compassionate Licensed Practical Nurses...

  • LPN - Licensed Practical Nurse - Full Time

    2 months ago

    Ridgefield, United States Benchmark Senior Living Full time

    Join, stay, and grow with Benchmark. Connect with your calling.Benchmark Senior Living invites you to explore career opportunities that embrace your talents and aspirations! At Benchmark, we are dedicated to providing exceptional care and support to our senior residents. We are currently seeking compassionate Licensed Practical Nurses (LPN) with a genuine...

  • LPN - Licensed Practical Nurse - Full Time

    3 weeks ago

    Ridgefield, United States Benchmark Senior Living Full time $32 - $37

    Join, stay, and grow with Benchmark. Connect with your calling.Check below to see if you have what is needed for this opportunity, and if so, make an application asap.Benchmark Senior Living invites you to explore career opportunities that embrace your talents and aspirations! At Benchmark, we are dedicated to providing exceptional care and support to our...

  • LPN - Licensed Practical Nurse - Full Time

    1 month ago

    Ridgefield, United States Benchmark Senior Living Full time

    Job DescriptionJoin, stay, and grow with Benchmark. Connect with your calling.Benchmark Senior Living invites you to explore career opportunities that embrace your talents and aspirations! At Benchmark, we are dedicated to providing exceptional care and support to our senior residents. We are currently seeking compassionate Licensed Practical Nurses (LPN)...

  • LPN - Licensed Practical Nurse - Full Time

    1 month ago

    Ridgefield, United States Benchmark Senior Living Full time

    Job DescriptionJoin, stay, and grow with Benchmark. Connect with your calling.Benchmark Senior Living invites you to explore career opportunities that embrace your talents and aspirations! At Benchmark, we are dedicated to providing exceptional care and support to our senior residents. We are currently seeking compassionate Licensed Practical Nurses (LPN)...

  • LPN - Licensed Practical Nurse - Full Time

    1 month ago

    Ridgefield, United States Benchmark Senior Living Full time

    Job DescriptionJoin, stay, and grow with Benchmark. Connect with your calling.Benchmark Senior Living invites you to explore career opportunities that embrace your talents and aspirations! At Benchmark, we are dedicated to providing exceptional care and support to our senior residents. We are currently seeking compassionate Licensed Practical Nurses (LPN)...

  • Senior Medical Care Professional

    1 day ago

    Ridgefield, Connecticut, United States Benchmark Senior Living Full time

    Job Overview:    Benchmark Senior Living seeks a skilled Registered Nurse to join our healthcare team in delivering high-quality care to our residents. With a focus on providing a warm and home-like environment, you will be part of a dedicated team that prioritizes the well-being and comfort of our residents.Compensation:    This part-time position...

  • Senior Therapist PT

    2 weeks ago

    Ridgefield, United States Powerback Rehabilitation Full time

    Senior Therapist PT at Powerback Rehabilitation summary: The Senior Therapist at Powerback is dedicated to delivering holistic rehabilitation services designed to promote patient independence and well-being. This role involves clinical management, development of individualized therapy programs, and collaboration with other healthcare professionals to...

  • Skilled Nursing Associate

    2 weeks ago

    Ridgefield, Connecticut, United States Maplewood at Danbury LLC Full time

    We are seeking a skilled and compassionate Skilled Nursing Associate to join our team at Maplewood Senior Living in Danbury, CT.About Our CommunityOur community is designed to provide a warm and welcoming environment for seniors, promoting socialization and engagement. As a key member of our care team, you will have the opportunity to make a meaningful...

  • Senior Therapist PT

    2 weeks ago

    Ridgefield, United States SimplyApply Full time

    Powerback is a new way of delivering recovery, rehabilitation, respiratory, and wellness services to patients across the nation. We deliver an empowered approach to achieving your full potential by providing integrated and individualized solutions. Our reimagined approach to rehabilitation connects directly to the patient experience, which is centered on...

  • Executive Director

    3 hours ago

    Ridgefield, CT, United States Maplewood at Darien LLC Full time

    Job Title: Executive DirectorLocation: Darien, CTEmployment Type: Full TimeDepartment: AdministrationAbout Us: Maplewood Senior Living, is a leading operator of premier senior living communities across 5 states and Washington, D.C., featuring two distinguished brands: Maplewood and Inspr. Known nationally for innovation in the senior living space, Maplewood...

  • Powerback Rehabilitation | Senior Therapist PT | ridgefield, ct

    2 weeks ago

    ridgefield, United States Powerback Rehabilitation Full time

    Senior Therapist PT at Powerback Rehabilitation summary: The Senior Therapist at Powerback is dedicated to delivering holistic rehabilitation services designed to promote patient independence and well-being. This role involves clinical management, development of individualized therapy programs, and collaboration with other healthcare professionals to...

  • Senior Therapist PT

    2 weeks ago

    Ridgefield, CT, United States Powerback Rehabilitation Full time

    Senior Therapist PT at Powerback Rehabilitation summary: The Senior Therapist at Powerback is dedicated to delivering holistic rehabilitation services designed to promote patient independence and well-being. This role involves clinical management, development of individualized therapy programs, and collaboration with other healthcare professionals to...

  • Caregiving Professional at Danbury Senior Living

    2 weeks ago

    Ridgefield, Connecticut, United States Maplewood at Danbury LLC Full time

    We are seeking a dedicated Licensed Practical Nurse to join our team at Maplewood at Danbury LLC, a state-of-the-art senior living provider. This is an excellent opportunity to make a positive impact in the lives of seniors and be part of a dynamic team.As a Licensed Practical Nurse, you will be responsible for providing high-quality patient care,...

  • Medical Director

    3 weeks ago

    Ridgefield, Connecticut, United States Lifelancer Full time

    About the RoleWe are seeking a highly skilled Medical Director - Global Risk Management Therapeutic Area to join our team at Lifelancer.Job DescriptionThe Medical Director will be responsible for developing and implementing risk management strategies for assigned marketed and/or investigational compounds. This includes continuous assessment of the...

  • Director of Operations

    1 month ago

    Ridgefield, United States Compass Group USA Full time

    Greetings!Interviewing and hiring now.Come join The Compass Group and Eurest and a a growing Casino in Ridgeland, WA.ilani Casino Resort - Washington (WA) Casino Near Portland | ilani~ We are currently seeking a Director of Operations to lead and ensure the success of our operations, while maintaining strict adherence to the client’s culture and...

  • Director of Operations

    2 months ago

    Ridgefield, United States Compass Group USA Full time

    Greetings!Interviewing and hiring now.Come join The Compass Group and Eurest and a a growing Casino in Ridgeland, WA.ilani Casino Resort - Washington (WA) Casino Near Portland | ilani~ We are currently seeking a Director of Operations to lead and ensure the success of our operations, while maintaining strict adherence to the client’s culture and...

  • Senior Therapist PT

    5 days ago

    Ridgefield, CT, United States Powerback Rehabilitation Full time

    As the leader in physical, occupational, speech, and respiratory therapies, we help older adults stay active and thrive while providing essential therapy for children at home and in school. With over 38 years of trusted service, our reach spans skilled nursing centers, assisted and independent living facilities, outpatient clinics, and home-based care. If...

  • Global Learning and Development Lead in Pharmaceutical Industry

    2 weeks ago

    Ridgefield, Connecticut, United States Lifelancer Full time

    Overview of the PositionThe Senior Associate Director, Global Medical Affairs Learning & Training Lead is responsible for driving the global vision and strategy for the learning and development of non-customer facing medical affairs roles. This position requires a strong leader who can collaborate with other pillar leads in Global Medical Affairs as well as...