Baim Institute for Clinical Research – $68,432.00/Year

All Requirementsbr br Bachelors degree in pharmacy, medicine, regulatory affairs, or related Life Science field, plus 3 years experience developing safety plans for clinical studies.br br Experience, which may be gained concurrently, must include each of the followingbr br 3 years experience analyzing clinical trials to identify and differentiate AEs Adverse Events, SAEs Serious Adverse Events, endpoint events, UADEs Unanticipated adverse device effects, and SUSARs Suspected Unexpected Serious Adverse Reactions.br 3 years experience ensuring compliance with safety reporting regulatory requirements including ICH and GCP guidelines.br 3 years experience performing MedDRA and WHODRUG coding.br 3 years experience utilizing clinical databases such as Clinical Database preferred InForm, RAVE Medidata, iMednet ; eClinical OS, Argus, or Empirica Trace.br 3 years experience processing and delivering serious adverse and clinical event reports to sponsor companies and regulatory authorities FDA and EMA.