Lead PV Professional, UK and Ireland Risk Management Team

Date: Sep 6, 2024

Location:

Zagreb, Croatia, 10000

Company: Teva Pharmaceuticals

Job Id: 58152

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 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.

The opportunity

As a Lead PV Professional, as part of UK and Ireland Risk Management Team, you will:

• Support and perform Company Core Safety Information and SmPC/PIL review, and support the review and implementation of UK/IE National labelling changes

• Liaise with global colleagues on subject matter relating to UK/IE reference safety information/labelling documents

• Perform and monitor the development of safety activities relating to Risk Management Plans (RMP) including additional risk minimisation measures (ARMM), educational materials, pregnancy prevention programmes (PPP), controlled access programmes (CAP), controlled distribution systems (CDS) and DHPCs

• Participate in Risk Management team activities and support LSO and other members of the Risk Management team as required

• Liaise with commercial colleagues to develop a PV strategy for UK/IE products requiring ARMMs and liaise with competent/licensing authority, trade associations and other Marketing Authorisation Holders (MAH) where appropriate to secure approval of materials and communication plan

• Assess and review ad hoc safety issues relating to UK/IE marketed products

• Monitor and maintain documentation relating to Teva UK/IE products subject to additional monitoring

• Prepare and implement relevant PV training relating to ARMM for UK/IE products and other risk management activities relating to product safety as required

• Contribute to the monitoring and strengthening of local risk management related processes to ensure timely completion of relevant activities including CCSI comparisons, UK signal management process and PSUR submissions and implementation of additional risk minimisation measures

• Contribute to preparation and revision of local controlled documents relating to Risk Management local activities to ensure compliance with global/EU/UK standards

How you’ll spend your day

Company Core Safety Information:

• Perform comparisons and quality control (QC) of comparisons of Company Core Safety Information (CCSI) and National UK/IE SmPCs including liaison with UK/IE Regulatory Affairs and Medical Affairs as necessary

• Assist in the identification of potential safety variations to the UK/IE National SmPCs following discussion with relevant personnel as necessary e.g. UK/IE Regulatory Affairs, UK/IE Medical Affairs and the Teva Periodic Reports and Risk Management Centre (TPC)

• Perform a review of all notifications received from the CCSI Distribution System (DS)

• Update and maintain the CCSI TrackWise records

• Maintain the Safety Variation Tracker with respect to UK/IE related Safety Variations

Risk Management:

• Maintain TrackWise and other PV records relating to Risk Management Plans (RMPs) and Additional Risk Minimisation Measures (ARMMs) for UK and Ireland

• Create, update and develop strategy for ARMMs for existing and new launch products

• Attend launch team meetings and provide updates to stakeholders

• Assist in the handling and triaging of emails received to the Risk Management team inbox

• Assist in the processing of handling and responding to adhoc safety issues relating to UK and Ireland marketed products

• Assist in the maintenance of documentation relating to Teva UK and Ireland products subject to additional monitoring

• Maintain the UK and Ireland PSUR TW records and handling PSUR related notifications received to Safety UK mailbox, recording UK submissions to MHRA

• Support internal compliance activities relating to Risk Management activities (including PSUR, CCSI) and requests from TPC for record reviews/Extent of Implementation evaluations

• Handle signal notifications from global signal team as appropriate ensuring signals which require notification to MHRA are handled within applicable timelines

• Maintain the UK signal management tracking tool

• Support with maintenance of PV Risk Management team Activity Log

• Support with handling of health authority requests and Health Hazard Requests/Safety Assessments in a timely manner

Other tasks:

• Support with triage of Safety UK and Risk Management email inbox

• Provide support to LSO with other tasks as required

• Work with Risk Management colleagues to identify and implement continuous process improvements

Your experience and qualifications

• Bachelor’s Degree in Life Sciences

• Significant Pharmacovigilance experience (3+ years)

• Broad knowledge of applicable national and EU Pharmacovigilance legislation and guidance

• Very good attention to detail

• Good communication skills in both verbal and written English

• Ability to plan, organise and prioritise tasks

• Work independently and as part of a team

• Ability to demonstrate pro-activity and work under pressure to meet tight deadlines

• Project management

• Microsoft Office, TrackWise

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, 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. 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.

EOE including disability/veteran