Senior Manager, Contractor, of Compliance and Drug Safety and Pharmacovigilance Operations
audits including USA/MHRA/EMA PV inspections....
audits including USA/MHRA/EMA PV inspections....
across phases. Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures...
and resolution). Prior experience with quality in a cGMP setting. Experience working with regulated GMP systems and FDA, EMA...
(i.e. cGMP, FDA, EMA) required, with direct experience supporting biannual or pre-approval inspections preferred...
clinician role in NextGen PM and EMA EHR and monitors, assigns and personally participates in delivery of EMR and coding...
are not an exhaustive list;EMA would be happy to discuss a customized position based on your background and interests and the needs of the...
. We have a state of the art, fully integrated EMR (EMA) and we employ the area’s best, top quality administrative and clinical support...
standards (e.g., FDA, EMA). b. Reports critical incidents and negative trends to plasma center Operations team and Regional... be considered. 2. One (1) year experience in a Quality Assurance role required. 3. Demonstrated knowledge of FDA, EMA, ISO...
from an accredited institution with experience in parasitology Knowledge of regulatory requirements (e.g. FDA, EMA) and compliance...
with relevant regulatory guidelines (FDA, EMA). Maintain rigorous quality control standards throughout the process development...