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Medical Director, Medical Safety Assessment, Immunology

Employer
Bristol Myers Squibb Company
Location
Princeton, NJ, United States
Start date
Jun 18, 2019

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Discipline
Administration, Clinical, Drug Safety/Pharmacovigilance
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

Summary

The Medical Director will function as a Medical Safety Assessment Physician (MSAP), supporting assets in the Immunoscience therapeutic area. The MSAP serves as the BMS expert on all aspects of medical drug safety for assigned assets in the BMS portfolio. The MSAP chairs the cross-functional Medical Surveillance Team (MST); MSTs conduct safety review and analysis and describe the safety profile of BMS assets. The MSAP works closely with partners within the pharmacovigilance department and the broad BMS organization.

Responsibilities
  • Lead all medical safety assessment and related activities for assigned assets in the Immunoscience therapeutic area
  • Chair the MSTs for assigned assets
  • Conduct proactive signal detection activities
  • Establish and maintain the risk profile of assigned assets
  • Evaluate data from multiple sources, including clinical, nonclinical and real-world, to understand safety signals
  • Characterize safety concerns to support risk assessment
  • Be accountable for risk strategy, risk assessment, and risk minimization in partnership with other BMS functions
  • Collaborate with colleagues to review protocols and study reports and contribute to proactive planning of studies related to safety assessments
  • Serve as a safety consultant for product development activities
  • Lead or act as a key contributor to medical safety query responses
  • Serve as the medical safety lead for aggregate safety reports and strategic documents; provide medical evaluation of aggregate safety data and develop and write medical sections of periodic reports (eg, PBRERs, DSURs)
  • Contribute to departmental and cross-functional improvement initiatives
  • Ensure that the above tasks are performed in the most efficient manner possible with quality and accuracy and in accordance with any relevant global regulatory requirements
  • Serve as a trusted partner to other functions in representing the view on product safety
  • Lead in a matrix environment through scientific competency and organizational influence
  • Promote collegiality and teamwork among peers, and mentor/support colleagues in the department as a positive change agent


Background/Experience
  • A Medical Degree is required
  • A doctoral degree and/or MPH is desirable
  • At least 3 years in pharmacovigilance or relevant pharmaceutical or biomedical field is strongly preferred
  • Postgraduate qualification or experience in immunology or related specialty is desirable
  • Other relevant experiences and accomplishments will be considered, such as roles in clinical and observational research and clinical practice experience


Competencies/Knowledge/Skills
  • Understanding of the drug development process
  • Knowledge of pharmacovigilance and ability to apply knowledgeto evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug
  • Ability to leverage the range of available tools to investigate safety concerns, including the science of observational research
  • Understanding of regulatory requirements for safety assessment and action
  • Strong scientific analytical reasoning skills
  • Ability to work on multiple complex projects in parallel
  • Exceptional attention to detail
  • Behavioral competencies necessary to work and lead within a matrix environment
  • Excellent verbal and written communication skills

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
 New York
New York
10016
United States
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