Group 10
ProductLife Group is looking for a Data Officer (Pharmacovigilance) to have responsibility for allocated tasks within the pharmacovigilance activities delivered by the platform.
Group 10 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)
- Monitoring a generic mailbox and support in the registration and the initial triage in the database
- Quality control of vigilance cases
- 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
Group 11 Education & Experience
Bachelor’s degree in science related fieldFresher or 1 year of PV experienceWell versed with Outlook and Microsoft OfficeGroup 13 Skills
Database experience preferredProcess orientedEnjoys working with documentationGood computer skillsWorks well within a teamKnowledge of medical terminologyOrganizedFlexibleExcellent communication skills in English and French