Pharmacovigilance Associate UKIE - 1 year FTC

Date: Mar 27, 2024

Location:

Harlow, United Kingdom, CM20 2FB

Company: Teva Pharmaceuticals

Job Id: 54962

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of innovative generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

We would like to invite applications for the role of Pharmacovigilance Associate forUKIE  to 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.

Location : Harlow. We have a hybrid approach to home working!

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

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 DI focused company. Clickhere to learn more about DI at Teva.

Reports To

Senior Manager, Deputy LSO UK and Ireland

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, colour, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.#TJ

EOE including disability/veteran