Description
The Pharmacovigilance Scientist will be responsible for the timely case management of spontaneous and clinical trial reports including the data entry, QC, follow-up, E2b electronic reporting of adverse reactions received from worldwide sources; in addition, reporting of events to Ethics Committees and Investigators. This will involve liaising with global pharmacovigilance colleagues including CROs to ensure that the events have been entered correctly and submitted successfully to European regulatory authorities. It is beneficial that the Pharmacovigilance Scientist has prior working knowledge of the regulatory reporting requirements in Europe and a thorough understanding of all case processing activities from pre and post marketing sources. The Pharmacovigilance Scientist will also be required to assist with the preparation of the procedural documentation for European pharmacovigilance and clinical safety activities.
Job Duties and Main Responsibilities:
*Case management of reports from all sources
*Triage, data entry and QC of case reports into the global safety database
*Review of case reports, identify follow-up, compile follow-up queries
*Preparation of case narratives and performs MedDRA coding
*Coordinates medical review and follow-up of case reports
*Performs timely E2b electronic reporting to the EMA and EU regulatory authorities
*Performs case reconciliation activities
*Assists in the Preparation of Pharmacovigilance SOPs and Work Instructions
*Assists with the Clinical safety activities e.g. preparation of Safety Management Plans, SAE Reconciliation Plans, templates; reporting to Ethics Committees, Investigators
*Participates in process improvements and any other projects assigned by the Pharmacovigilance Manager
*Maintains good up-to-date knowledge on European pharmacovigilance regulations, particularly associated with electronic reporting
*General administration as required
Qualifications and Experience:
*Life Sciences or nursing degree
*Minimum of one to two years' prior experience in pharmacovigilance
*Good working knowledge of EU pharmacovigilance legislation and clinical safety requirements
*Good experience in the case processing of events
*Excellent coding and narrative writing skills
* Understanding of EudraVigilance E2b transmission and acknowledgement messages
*Ability to evaluate reports and draw conclusions independently
*Ability to prepare clear, concise and unambiguous pharmacovigilance documentation
*Ability to interact effectively with Regulatory authorities
*Ability to interact effectively with global offices to resolve case processing issues as required
*Ability to take ownership of assigned cases
*Previous experience of using safety databases is essential - Argus safety preferable
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk
