Boehringer Ingelheim Senior Associate Director/Director, Medical Safety in RIDGEFIELD, Connecticut
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.
The Director has responsibility for the pharmacovigilance risk management activities of 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.
*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 core strategic* marketed and/or investigational compounds
*as defined by GPV Management Board
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
Periodic Benefit Risk Evaluation Reports / 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
Depending on the status of development of the compound, lead, manage and medical-scientifically direct a team of risk management physicians responsible for a compound/product or project including project management, 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
US MD or DO degree or international equivalent from an accredited institution
Pharmaceutical/Biotech/CRO industry experience in one of the following areas:
Pharmacovigilance and Risk Management
Regulatory Affairs (preferably some experience in Pharmacovigilance and Risk Management)
One (1) to three (3) years leadership and project management experience
Total applicable experience (clinical plus industry) minimum of five (5) years
International business experience
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
Leadership and project management competencies
Excellent interpersonal and communication skills (both written and oral)
Desired Skills, Experience and Abilities:
Board certification/experience in metabolic disease, pulmonology, oncology, neurology, immunology or biosimilars would be an asset
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
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 at http://www.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., Merial Barceloneta, 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; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Organization: US-BI Pharma/BI USA
Title: Senior Associate Director/Director, Medical Safety
Requisition ID: 189176