Data Officer

General mission

The Data Officer's job is to guarantee the optimised management of vigilance data, both in terms of safety, administration, including traceability, in terms of the integration of this data into the various tools available (authorities, customer tools, internal tools) and to carry out the initial use of this data via ad hoc extractions in accordance with the objectives defined upstream. He/she also contributes to the proper organisation of his/her Line Of Business.

Qualification:

BPharm/MPharm

Experience Required:

1-3 years in

Main activities and technical skills required:

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.

Additional activities:

• Database extraction of data for the calculation of KPIs.
• Preparation of activity reports for clients and activity monitoring for the calculation of quality / performance indicators.
• Support for the coordination of activities (including planning and monitoring) ensuring effective
• communication to the coordination team regarding cases received with short timelines to meet regulatory deadlines.
• Provision of weekly/monthly/quarterly/yearly reports and activity monitoring for transmission to clients.
• Participation in audits to present the activity.
• Manage the processes related to the division's activities and to ensure their proper implementation within the division.