Teva Pharmacovigilance Associate UK & IE - year FTC 

United Kingdom, England 

861038972

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.

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

• 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.

Senior Manager, Deputy LSO UK and Ireland

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