Case Specialist 196,197,198

7 hours ago

Capital District, Philippines Groupe ProductLife Full time

ProductLife Group is looking for a Case Specialist to join our dynamic team to contribute to the activities performed in the Hub:

Responsibilities:
  • Data entry of vigilance cases in the relevant databases according to relevant conventions
  • Quality control of vigilance cases and other documents associated to safety reports
  • Medical review of vigilance cases according to relevant conventions and regulatory requirements
  • Follow-up request of vigilance cases by phone/mail
  • Pre-analysis of complex cases before data entry
  • Identification of submission requirements for safety cases
  • Identification of requirements in terms of preparation of ICSR/MLM filters
  • Review and analysis of ICSRs downloaded from competent authorities databases
  • Performing reconciliations (partners, medical information, quality complaints)
  • Participation in the operational implementation of new projects
  • Key contact for projects (with support of the team leader/Activity manager/Project manager)
  • To perform medical review of post marketing cases as assigned.
  • To be the Operations lead for assigned post marketing clients.
  • Drafting/updating of technical agreements /safety management plan /client template
  • Drafting/updating of SOPs/WPDs/Trainings others documents directly related to their activity
  • Participation in the implementation/maintenance/improvement of processes
Education and Experience
  • Pharmacist or Life Sciences degree with more than 3 years experience in PV
Profile:
  • Previous experience working to deadlines.
  • Client communications
  • Minimum 3 years experience working for service providers performing QC of cases
  • Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
  • Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment.
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