CLINICAL RESEARCHERMBBS MD MEDICAL REVIEWERPHARMACOVIGILANCE PHYSICIANDRUG SAFETY PHYSICIANPHARMACOVIGILANCE GENERAL MEDICINEDRUG SAFETY GENERAL MEDICINE
Experience
1 to 5 Years
Industry
Pharma / Biotech / Life Science
Functional Area
Medical Professional / Healthcare Practitioner / Technician
Job description
This is a senior position in the Company having the distinct duties associated with the assessment, input and clinical expertise for all medical case summaries, and assessing the safety within patient populations for a variety of investigational and marketed products on behalf of clients.
Job Duties & Responsibilities
· Medical review of cases on Company validated database
· Review of safety information from clinical trials and post marketed products
· MedDRA coding and assessments
· ICSR case file productions and archiving
· Filing of ICSRs and source documentation
· Causality assessments for ICSRs
· Understanding and helping with determining ICSR reportability
· Literature assessments for ADRs and medical reviews of articles
· Assessing adverse reactions for potential signals
· Display necessary skills for working under deadlines
· Show the ability to accurately enter safety data into the Company safety database
· Ensure reports are properly filed and stored
· Ensure that clients are fully briefed on information being requested
· Maintain Company compliance