Product Safety Scientist

United Therapeutics Corporation

1d • Onsite

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

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level