Drug Safety Specialist
CurrentPerforms safety case processing tasks including, but not limited to:• Intake tasks• Reviewing incoming safety information for completeness and accuracy• Ensure that all patient identifiers (PHI) in source documents (SD) have been completely redacted• Coordinate translation of source documents, if applicable and ensure reports are sent to the customer within assigned deadlines.• Tracking and data entry with coding of relevant medical terminology• Writing clinical narrative.• Generating queries• Contacting sites for missing and/or unclear information• Generating regulatory reports• ReconciliationPerforms other related duties as assigned or requested by Safety Management• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events (AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives, Literature related activities.• To meet the requisite turnaround time for expedited reporting per client expectations with timely generation and submission of MedDEV reports on a weekly basis, as per country specific submissions.• Solid knowledge of clinical research process and medical terminology.
