A day in the life of a Pharmacovigilance Associate…
Case Management:
Triaging of spontaneous and solicited ICSRs and SAEs received by Teva for authorised and marketed and development products in UK/IE
Entering of ICSRs and SAEs into Vsafe
Requesting follow-up information for ICSRs and SAEs, as necessary
Completion of the Global Lot Monitoring Tracker every month
Completion of the Global SME Follow up overview process report every month
Completion of the Master Follow up Tracker every month
Completion of the quarterly Global outcome pregnancy trackers
Completion of the Daily line listing
Reconciliation of ICSRs and SAEs exchanged between UK/IE Pharmacovigilance and relevant Teva UK/IE interfaces
Managing any UK/IE case related queries and escalating any complaints/medial queries/health authority requests to LSO and DLSO for relevant inputs
Clinical trials:
Collecting, filing and maintaining the documentation for UK/IE clinical trials/studies/other programmes, and to keep it updated with all the relevant information e.g. safety management plans, protocols, investigator brochures, safety agreements, as necessary
Ensuring reporting and submissions are performed in accordance with the responsibilities defined in the clinical trial/studies spreadsheet
Interacting with R & D personnel (internal and external), investigators and Global Patient Safety Operations, as necessary
DSURs:
Managing the submission of DSURs to the MHRA/HPRA (as appropriate) and Ethics Committees. To maintain the local DSUR planning and submission tracker Global Safety Database/PV Systems:
Resolution of any local issues arising during day-to-day use. Liaising with Global Patient Safety & Pharmacovigilance in this respect
Providing local inputs to Pharmacovigilance systems and systems development, as required
Delivering training in drug safety systems and associated procedures, as necessary
Compliance tasks:
Maintain, update and review of local controlled documents relating to Case Management team responsibilities to ensure compliance with global/national/EU standards.
To perform gap analysis on new or updated Global SOP/WIs vs UK/IE Addendums
To be the UK/IE Case Management SME in audits and inspections
Other tasks:
Supporting the UK/IE LSO/deputy as required
Performing and providing additional support for other Pharmacovigilance and Medical department activities as necessary
Who we are looking for
Do you have…?
Life Science degree preferred
Significant experience in Pharmacovigilance
Konwledge of Local (UK/IE) and EU PV regulatory requirements
Microsoft Office suite knowledge
Attention to detail
Are you…?
Organised
Multi-skilled
Fast learner
Able to prioritise
Proactive
