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Pharmacovigilance Officer UK&IE - 12m FTC

Date: Nov 24, 2021

Location: Harlow, GB, CM20 2FB

Company: Teva Pharmaceuticals

About us

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

 

We are currently looking for a Pharmacovigilance Officer for the UK&IE to cover a 12 month fixed-term contract. This is a full-time position joining the Global Medical Affairs & Pharmacovigilance, R&D department to perform appropriate processing of in-bound and out-bound Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) on the Teva UK/IE marketed and development products.

A day in life of a Pharmacovigilance Officer...

 

Case Processing:

  • Performing processing of spontaneous ICSRs and SAEs received by Teva for authorised, marketed and development products in the UK/IE, and forwarding to Global Drug Safety in accordance with international regulatory requirements and Teva standards
  • Requesting and processing follow-up information for ICSRs and SAEs, as necessary
  • Performing Quality Control of processed ICSRs and SAEs within UK PV, as necessary
  • Assisting as necessary, the expediting of relevant ICSRs and SUSARs, to the MHRA and HPRA via the global safety database

 

Reconciliation

  • Perform on time adverse event reconciliation between 3rd parties companies and Teva according to the relevant Safety Data Exchange Agreement (SDEA) and provide the necessary administration and filling of the reconciliation process.
  • Perform the reconciliation between Teva and external Service Providers and provide the necessary administration and filing of the reconciliation process.
  • Perform reconciliation of ICSRs and SAEs exchanged between Teva internal departments
  • Notify any concerns related with reconciliation with the Senior PV Officer or UK/IE PV Operations Manager or in their absence the UK/IE LSO.

 

Clinical trials:

  • Ensuring reporting and submissions are performed in accordance with the responsibilities defined in the safety management plans
  • Collecting, filing and maintaining the documentation for UK/IE clinical trials, and to keep it updated with all the relevant information, e.g. safety plans, protocols, investigator brochures, safety agreements, as necessary
  • Interacting with  R&D personnel (internal and external),  investigators  and global  Drug Safety, as necessary

 

Other tasks:

  • Providing additional support for other Pharmacovigilance department activities, as necessary.

Qualifications

 

Do you have...?

  • Bachelor's Degree (preferably in Life sciences)
  • Pharmacovigilance experience
  • Excellent knowledge of applicable national Pharmacovigilance legislation
  • Broad appreciation of global regulatory requirements for Pharmacovigilance
  • Attention to detail

 

Are you...?

  • Excellent at priority setting
  • Good team player
  • Flexible minded

 

What do we offer you?

  • 12 months Fixed-Term Contract
  • 25 days annual leave/year plus Bank Holidays
  • Flexible benefits including health insurance, life assurance, critical illness insurance, gym-flex and cycle to work scheme
  • Programme of Well-being initiatives including on-site Creative Rooms, Employee Assistance Programme, Wellbeing Champions

Function

Regulatory Affairs

Sub Function

Pharmacovigilance

Reports To

Senior Pharmacovigilance Officer - ICSR

Already Working @TEVA?

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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, color, 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.