Pharmacovigilance/
Drug Safety (Coordinator to Lead) @ COVANCE
Education/Qualifications:
Drug
Safety associates with a minimum a bachelor's degree in a Health Science
Discipline (B.Pharm, M.Pharm, Nursing, Medicine or Dentistry-qualified HCP
equivalent to Canadian HCP training) is required.
Drug Safety Associate with at least 6 months of PV experience with
case processing and an understanding of the FDA, EU and Canadian
Pharmacovigilance regulatory requirements and knowledge of Local ADR databases
is preferred.
Job Overview:
Assist with the overall Clinical Safety and/or PV&DSS
operations associated with products including the entire adverse events
process: which may include safety data collected from clinical trials and/or
post marketing setting (i.e., unsolicited reports).
Manage and process expeditable adverse events to the required
standard and submit them to the client and the regulatory agencies (if
required) within the agreed/stated timelines. The post holder is responsible
for providing this service to clients either as a support function to the
client project groups or as stand-alone business.
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