Pharmacovigilance Associate UK&IE

2 weeks ago

Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time
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 for UK&IE 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 D&I focused company. Click here to learn more about D&I 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

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


  • Regulatory Affairs Associate

    2 weeks ago

    Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time

    About the Company and Job TitleWe are Teva, a hidden gem in the pharmaceutical industry, touching the lives of millions of patients worldwide. Currently, we are searching for a talented individual to join us as a Regulatory Affairs Associate. Interested in ensuring high-quality healthcare access globally?Location: We are open to candidates near our sites in...

  • Director, Medical Affairs

    2 weeks ago

    Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time

    Who we areTogether, 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 &...

  • Director, Medical Affairs

    3 weeks ago

    Harlow, Essex, United Kingdom Teva Pharmaceuticals Full time

    Who we areTogether, 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 &...

  • Collections Associate I

    2 weeks ago

    Harlow, Essex, United Kingdom Arrow Electronics, Inc. Full time

    Position:Collections Associate IPrincipal Accountabilities Collects to termsnegotiates payment plans; may need to elevate cash flow problems according to mgmt reporting structure. Takes appropriate action such as credit hold, placement with collections; ability to work independently done with little or no guidance. A/R disputesworks with customer to...

  • Collections Associate I

    4 weeks ago

    Harlow, Essex, United Kingdom Arrow Electronics Full time

    Position:Collections Associate IJob Description:Principal Accountabilities Collects to terms—negotiates payment plans; may need to elevate cash flow problems according to mgmt reporting structure. Takes appropriate action such as credit hold, placement with collections; ability to work independently done with little or no guidance. A/R disputes—works...

  • Associate Director, Clinical Supply Chain QA

    2 weeks ago

    Harlow, Essex, United Kingdom GSK Full time

    Site Name: UK - Essex - HarlowPosted Date: Apr We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale,...

  • Operational Engineer

    2 weeks ago

    Harlow, Essex, United Kingdom UK Power Networks Full time

    Operational EngineerThis Operational Engineer will report to Client Delivery Manager and will work within UKPN Services - Client Delivery based in our Stanstead Airport office. You will be permanent employee.You will attract a salary of £76,229 plus car and a bonus of 3% Should you not have the full range of essential skills, qualifications and...

  • Sales & Estimating Manager - (CCTV/Access Control) (Permanent)

    2 weeks ago

    Harlow, Essex, United Kingdom Recruitment Services UK Full time

    Job title: Sales & Estimating ManagerReporting to: Managing DirectorResponsible for: Estimating and SalesWork Location Harlow – CM20 2BDOur client Gamma Systems was established in 1999, and they have strived to become market leaders in providing Communal IRS, Security and Fire Protection Solutions in and around London. Their clients range from Principal...

  • Cleaner - Approx 11 Hours Per Week

    2 weeks ago

    Harlow, Essex, United Kingdom Adecco Full time

    Cleaner - Approx 11 hours per weekAdecco, Harlow are currently recruiting for a part time office cleaner, based in Harlow.This position is ongoing/Temp - PermHours: afternoonsDays:3 days per week, with most hours covered on FridayLocation: HarlowDuties: General office cleaningEnjoy exclusive benefits alongside new opportunitiesAs one of our talented...

  • Forklift Driver X3

    2 weeks ago

    Harlow, Essex, United Kingdom Adecco Full time

    Forklift DriverHarlowMonday to FridayForklift work available within a leading suppliers of carpet.Benefits Onsite parking Bike Scheme 29 days holiday Adecco benefits schemeAdecco Harlow are proud to be working with a carpet company, who are looking for X3 Forklift Drivers.Duties Loading and unloading carpet using a boom Stock control Moving stock around the...

  • X4 Inbound Call Centre Advisor

    2 weeks ago

    Harlow, Essex, United Kingdom Adecco Full time

    x4 Inbound Call Centre Operative (Claims Advisor)HarlowTemporary workMonday to FridayWould you like to work with a company with solid foundations that can offer you progressional route and have a fantastic culture?Benefits Onsite parking Bike Scheme 29 Days Holiday Adecco benefits schemeAdecco Harlow are proud to be working with a Leading business within...

  • Biomedical Engineer

    4 weeks ago

    Harlow, Essex, United Kingdom Focus Resourcing Full time

    It is ESSENTIAL that you have experience of working in a UK hospital and have the necessary certificates of training from the original equipment manufacture to apply for this role. As the Biomedical Engineer, you will be responsible for: Performing preventative maintenance on medical equipment as per manufacturers guidelinesCompleting repairsCompleting...

  • Senior Application Engineer

    2 weeks ago

    Harlow, Essex, United Kingdom Head Resourcing Full time

    Head resourcing is looking for a Senior applications engineer for a aerospace and defence company. The role is hybrid with office travel required to the offices in Harlow or Glenrothes 2 days per week.This roles primary function is to support the Windchill PDM solution, but to also support the business in more general engineering applications. The function...

  • Senior application engineer

    2 weeks ago

    Harlow, Essex, United Kingdom Head Resourcing Full time £55,000 - £65,000

    Head resourcing is looking for a windchill engoneer for a aerospace and defence company. The role is hybrid with office travel required to the offices in Harlow in Essex or Glenrothes 2 days per week. This roles primary function is to support the Windchill PDM solution, but to also support the business in more general engineering applications. The function...

  • Head of Advanced Product Sales

    4 weeks ago

    Harlow, Essex, United Kingdom RTX Full time

    Date Posted: Country:United KingdomLocation:GBR01:Harlow, Essex, Kao One, Kao Park, Harlow, CM17 9NAPosition Role Type:UnspecifiedAPPLICATION CLOSING DATE: FRIDAY 22ND MARCHHead of Advance Product SalesGrade: M5Location: Harlow/London - hybrid role with a customer base in the South EastSummary of RoleIn this role, you will be responsible for leading a small...

  • Head of Advanced Product Sales

    1 month ago

    Harlow, Essex, United Kingdom RTX Full time

    Date Posted: Country:United KingdomLocation:GBR01:Harlow, Essex, Kao One, Kao Park, Harlow, CM17 9NAPosition Role Type:UnspecifiedAPPLICATION CLOSING DATE: FRIDAY 22ND MARCHHead of Advance Product SalesGrade: M5Location: Harlow/London - hybrid role with a customer base in the South EastSummary of RoleIn this role, you will be responsible for leading a small...

  • Head of Advanced Product Sales

    2 weeks ago

    Harlow, Essex, United Kingdom Raytheon Technologies Corporation Full time

    Date Posted: Country: United Kingdom Location: GBR01:Harlow, Essex, Kao One, Kao Park, Harlow, CM17 9NA Position Role Type: Unspecified APPLICATION CLOSING DATE: FRIDAY 22ND MARCH Head of Advance Product Sales Grade: M5 Location: Harlow/London - hybrid role with a customer base in the South East Summary of Role In this role, you will be...

  • Electromechanical Technician

    2 weeks ago

    Harlow, Essex, United Kingdom Raytheon Technologies Full time

    Unspecified Summary of Role The Weapons area primarily supports the design, development, production, and integration activities associated with the Weapon Systems. As a result of new contracts, the engineering team is looking for a motivated Electromechanical Technician. As an Engineering Technician within Raytheon, you will collaborate with a team...

  • Technical Customer Service Engineer

    2 weeks ago

    Harlow, Essex, United Kingdom Concept Resourcing Full time

    Are you an experienced engineer in the biomedical sector with a qualification in the same area? We have an exciting new opening for a Technical Services Engineer in our Harlow offices. Role Provide technical support activities where needed across all departments Complete repairs for our return to base service. Manage e-quip spare parts data including the...

  • Warehouse Supervisor

    2 weeks ago

    Harlow, Essex, United Kingdom Bidfood Full time

    Bidfood is a leading wholesale food distributor and the preferred supplier for over 60,000 customers across the UK, ranging from pubs to schools, from restaurants to care homes and everything in between. From Lands' End to John O'Groats, we deliver great food and other catering products to a huge range of customers across the region, whether our customers...