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Teva Pharmacovigilance Associate UK & IE - year FTC 
United Kingdom, England 
861038972

25.06.2024

We would like to invite applications for the role ofPharmacovigilance AssociateforUK&IEto oversee the smooth running of the UK/IE Case Management team activities and related processes, ensuring the handling of in-bound and out-bound Individual Case Safety Reports (ICSRs) and Adverse Events (AEs) on the Teva UK/IE pre and post marketed products in accordance with local/EU legal requirements.


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

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
Enjoy a more rewarding choice
  • Enjoying time with your families (25 days of annual leave, Pension scheme)
  • Looking after your health (Life & Critical Illness Insurance, Private health insurance, Sports and Health Programme – including health days and nutritional counselling, On-site Canteen)
  • Recognizing your value (Recognition programs to reward our employees with our company bonus scheme)
  • Boosting your potential (Virtual Learning Centre)
  • Well-being and D&I focused company. Click to learn more about D&I at Teva.
Reports To

Senior Manager, Deputy LSO UK and Ireland

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