BioCT Innovation Commons
Director, Medical Safety Physician - Oncology (Remote)
BioCT Innovation Commons, Ridgefield, Connecticut, us, 06877
The Medical Safety Physician will join our motivated and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. This is a highly visible role for an individual with a strong medical/scientific background 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.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
Work in cross-functional expert teams to 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:
Periodic Benefit Risk Evaluation Reports / PADERsDevelopment Safety Update ReportsRisk Management PlansClinical Overview StatementsContinuous monitoring and further development of the product safety profileSafety issue managementSet-up of safety analyses in both post marketing and clinical trial databasesClose collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiologic studiesReview and medical-scientific input to regulatory documents
Requirements
Director Requirements:US MD or DO degree or international equivalent from an accredited institution and more than 5 years of applicable experience, required.Leadership experience highly preferred.Preferred experience/expertise in clinical practice beyond training with a strong medical/scientific knowledge, and/or experience with case/medical review.Board certification / experience in a medicine subspecialty, would be an asset.Excellent interpersonal and communication skills (both written and oral) required.Highly ethical personality putting patient safety first.Self-starter and driving personality, willingness to take on responsibilities.Ability to synthesize large amounts of medical data and draw medical conclusions.Understanding of the pharmaceutical industry and regulatory environment.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.Desired Skills, Experience and Abilities
This position offers a base salary typically between $183,000 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.
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Work in cross-functional expert teams to 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:
Periodic Benefit Risk Evaluation Reports / PADERsDevelopment Safety Update ReportsRisk Management PlansClinical Overview StatementsContinuous monitoring and further development of the product safety profileSafety issue managementSet-up of safety analyses in both post marketing and clinical trial databasesClose collaboration with Global Epidemiology and Medical Affairs on safety-focused clinical and epidemiologic studiesReview and medical-scientific input to regulatory documents
Requirements
Director Requirements:US MD or DO degree or international equivalent from an accredited institution and more than 5 years of applicable experience, required.Leadership experience highly preferred.Preferred experience/expertise in clinical practice beyond training with a strong medical/scientific knowledge, and/or experience with case/medical review.Board certification / experience in a medicine subspecialty, would be an asset.Excellent interpersonal and communication skills (both written and oral) required.Highly ethical personality putting patient safety first.Self-starter and driving personality, willingness to take on responsibilities.Ability to synthesize large amounts of medical data and draw medical conclusions.Understanding of the pharmaceutical industry and regulatory environment.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.Desired Skills, Experience and Abilities
This position offers a base salary typically between $183,000 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.
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