Product Safety Scientist

United Therapeutics Corporation

285d

About The Position

The Product Safety Scientist will serve as a recognized leader within the Product Safety Risk Management Matrix Team (PSRMMT), collaborating with a Brand Safety Lead (BSL) and cross-functional stakeholders to manage the safety profile for assigned product(s) throughout their lifecycle. Responsible for providing scientific and analytical expertise and for leading and executing safety and benefit-risk management strategy.

Requirements

• Bachelor's degree in a health or science discipline and 5+ years of experience with safety risk management processes and procedures
• Master's degree in a health or science discipline and 3+ years of experience with safety risk management processes and procedures
• PharmD/PhD (or international equivalent) and 1+ years of experience with safety risk management processes and procedures
• Clinical knowledge of medical concepts/conditions and associated pathology to identify and analyze potential safety issues
• Intermediate understanding of pharmacology and toxicology to interpret data from a safety perspective
• Intermediate knowledge of pharmacovigilance processes and regulatory requirements
• Intermediate knowledge of MedDRA coding conventions and dictionaries

Nice To Haves

• Master's Degree in a health or science discipline
• Doctor of Philosophy (PhD) in a health or science discipline
• Doctor of Pharmacy (PharmD)
• 1+ years of previous experience using Argus or other safety database including signaling tools
• 1+ years of previous experience with document management systems, e.g. Documentum, Veeva
• 1+ years of clinical or academic publication experience

Benefits

• medical / dental / vision / prescription coverage
• employee wellness resources
• savings plans (401k and ESPP)
• paid time off & paid parental leave benefits
• disability benefits

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree