
Case Specialist 196,197,198
3 weeks ago
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
- Pharmacist or Life Sciences degree with more than 3 years experience in PV
- 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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