Medical Safety Dir

About the role

The Medical Safety Director participates in all aspects of Medical Safety’s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. The Medical Safety Director also provides global project leadership on projects requiring multiple medical safety advisors and mentorship to junior medical safety staff.

What you'll do

• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data

What you need

• Clinical research
• Pharmacovigilance
• Quality control
• Communication
• Any graduate