- Provide medical safety expertise, directly and indirectly, to Sponsors of drugs, devices, and combination products, in the post-marketing period.
Summary of Responsibilities:
- Responsible for Signal Detection and evaluation activities for assigned products.
- Undertake primary medical review of aggregate safety reports (PSURs, PADERs, PBRERs).
- Participate in ongoing safety surveillance and signal detection/analysis activities including aggregate data review /trend analysis.
- Facilitate and Participate in Drug Safety Meetings and Signal Analysis Meets, as required.
- Establish an excellent working relationship with the client medical team including Managers/leads as required.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
MBBS or MD or equivalent degree.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required): 3-5 years in Aggregate Reports & Signal Detection
