Data Officer

Mission

MANAGEMENT OF VIGILANCE DATA –

• Management of the generic or client specific email boxes as appropriate. - Initial registration of vigilance cases into internal tracking tool.
• Duplicate search in the safety database (Client or PLG) - Initial triage assessment and data entry, MedDRA, narrative writing of vigilance cases into the client safety database after checking for duplicates (or in pre-agreed formats defined with the client), including anonymization of patient data if applicable.
• Be able to identify the seriousness of the case with or without the support of medically qualified personnel and using IME list where applicable and assessment of submission requirements - Preparation of initial email (in the context of follow- up request), requests for clarification and acknowledgements for the follow up of vigilance cases.
• Case closure. - Submission of clinical or post-marketing cases to the Competent Authorities/ Ethics Committees/ Partners/Affiliates or other as appropriate.
• Client notification (where appropriate) according to requirements detailed in SDEA or Technical Agreement as applicable.
• Generate reports (summary tabulation) and listings (line listing) from the safety database as per request.
• Analysis of inclusion/exclusion for cases received from EV or MHRA ICSR download.
• Carrying out specific queries in the databases in order to draft reports
  

EUDRAVIGILANCE

• Setting up ICSR and MLM filters on the instructions of a Case Specialist.
• EV ICSR download and MLM search and submission of ICSR
• XEVMPD update and initial submission
  

MHRA/ FDA/ Other Competent Authorities

• Carrying out of MHRA/FDA/ other Competent Authorities ICSR download and submission of ICSR (as applicable).
  

WRITING SUPPORT

• Drafting/updating of technical agreements /safety management plan / client template (for a trial for example).
• Drafting/updating of procedures/ operating methods or others directly related to its activity.
  

Required Education

Required Experience

Required Technical Skills

Additional Experience And/or Skills