SPECTRAFORCE

• Delivers medical, clinical and scientific advisory expertise in clinical research studies and post marketing programs (RWI). • Signal detection and aggregated reporting. • Provides medical, scientific and therapeutic expertise on pharmacovigilance services. • Participates in all aspects of the Medical Safety activities as per scope of work. • Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary. • 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. • Represent safety and clinical data review findings during client meetings. • Provide medical review and edits of safety reports or other benefit-risk assessments.