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
