Description
We are seeking a Medical Safety Director to provide medical expertise on pharmacovigilance services to all divisions as requested.
The Medical Safety Director participates in all aspects of Medical Safety's involvement on assigned trials and standalone safety projects with appropriate oversight from management or more senior medical safety directors.
Key responsibilities include:
- Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
- Composing, editing and medically reviewing Analyses of Similar Events (AOSE) for expedited cases
- Serving as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
- Representing safety and clinical data review findings during client meetings
- Providing medical review and edits to various reports, including IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, and US Periodic Reports
- Providing medical oversight for label development, review and change
- Attending and contributing to Data Safety Monitoring Board Meetings and Safety Monitoring Committees
- Maintaining awareness of medical-safety-regulatory industry developments
Requirements include:
- A medical degree from an accredited and internationally recognized medical school
- Three years of clinical practice experience with four 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