Worldwide Clinical Trials
Associate Ii, Pharmacovigilance - Brazil - Remote
Job Description
What the Associate II, Pharmacovigilance does at WorldwideResponsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions. Serves as Lead PV Associate on moderate to large sized studies that are moderate to complex in scope of work with moderate support from senior staff.What you will doAuthor Safety Management Plan for assigned studiesAttend and present at Investigator MeetingsReview incoming SAE data for completeness and accuracyPerform data entry in the Safety Database and/or complete applicable tracking of incoming safety informationPerform QC of SAEs processed by other PV AssociatesGenerate regulatory reports and perform safety submissions as neededWhat you will bring to the roleStrong understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug...