Boehringer Ingelheim Senior Associate Director/Director, Medical Safety in UNITED STATES, United States
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. 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.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Senior Associate Director/Director, Medical Safety
Location: Americas-United States
Requisition ID: 189176