ProductLife Group is looking for a Data Officer to join our dynamic team and to contribute to the activities performed in the Hub:
Responsibilities:
- Data entry of vigilance cases in the relevant databases
- Preparation of initial email (in the context of follow up request), requests for clarification
- Submission of cases to the competent authorities
- Carrying out specific queries in the databases in order to draft reports
- Monitoring and downloading ICSRs in the national databases (Eudravigilance, MHRA portal)
- Recordings/updates on XEVMPD
- 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:
- Bachelor’s degree in science/ Industrial Biology/Chemistry Engineer/ Pharmacy
- Minimum 2 years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases
- Previous experience working to deadlines.
- Client communications
- Knowledge of EU PV regulations
- Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety.
- Knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
Skills:
- Database experience preferred
- Process oriented
- Enjoys working with documentation
- Good computer skills
- Works well within a team
- Knowledge of medical terminology
- Organized
- Flexible
- Excellent communication skills in English