Associate Medical Safety Director

Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate 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.

Key Responsibilities:

• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to various reports, including IND Annual Reports and EU Periodic Benefit Risk Evaluation Reports
• Provide medical oversight for label development, review and change
• Attend project meetings, medical safety team meetings, and client meetings as requested
• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines

Requirements:

• Medical degree from an accredited and internationally recognized medical school
• 7+ years of clinical practice experience in signal management activities, review of clinical trial documents, creation, analysis, and presentation of reports
• 9+ additional years in the pharmaceutical or associated industry
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research
• Ability to establish and meet priorities, deadlines, and objectives
• Valid medical license, or equivalent, from the country or region in which you reside and work