Data Officer

Location: Dombivali

Product Life 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
Min 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  US and EU PV regulations
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

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