RA & PV (Regulatory
Affairs, Pharmacovigilance) Intern – 6 months contract
Support the
establishment and maintenance of a local Pharmacovigilance (PV)
system
and support Regulatory
Affairs (RA) for competitor monitoring, RA documents Archive, Health
Authorities reporting, and other administrative activities.
Eventually, overall
support for maintenance activities to ensure patient's and clinical trial
subject’s safety and public health in the assigned territory, South Korea.
[Job Description]
-Support monitoring of competitor’s
CTA approval
-RA documents archive activities
-Support reporting to
Health Authorities (including official letter delivery, submission of saftey
reports and other maintenance activities)
-Draft Adverse Event case into Global
Safety System
-Translate Adverse Event case narratives
between English and Korean
-Handle the logistic
process for defective products (including courier arrangements, contacting
wholesalers)
