Pharmacovigilance SpecialistCook MyoSite Incorporated
Cook MyoSite Incorporated seeks Pharmacovigilance Specialist in Pittsburgh, PA, responsible for executing op. activities for clinical safety monitoring of investigational products. Receive & process individual case safety reports, evaluate cases for validity & consistency, & document cases according to procedures. MS in life science field, pharmacology, toxicology/medical discipline & 2 years of experience in pharmacovigilance/safety management, clinical research & safety surveillance/regulatory affairs required. Additional experience must include: work for sponsor of clinical trial; safety case processing for global clinical trials, event triage, establish procedures for & working in safety DBA, including data migration; MedDRA & WHODD coding; development & review of SOPs & CAPAs; & participation in preparation of aggregate reports. Must have current authorization to be employed in US without employer sponsorship.