Company Core Safety Information:
§ Perform comparisons of Company Core Safety Information (CCSI) and national UK SmPCs, including liaison with UK Medical Affairs and Regulatory Affairs, as necessary
§ Assist in the identification of potential safety variations to UK national SmPCs required, following discussion with relevant personnel as necessary e.g. UK Medical Affairs, UK Regulatory Affairs and the Global PSUR Writing Centre
§ Perform the review of all notifications received from the CCSI Distribution System (DS)
§ Maintain the Safety Variation Tracker with respect to UK related Safety Variations.
§ Perform the creation of safety variation changes in the Teva Change Control system for national UK licensed marketed products.
§ Assist in the implementation and monitoring of safety measures relating to European or UK- specific RMPs
§ Assist in the alerting of all relevant UK personnel to specific RMP requirements as necessary e.g. Medical Affairs, Regulatory Affairs, Marketing, Launch team
§ Assist in the review of RMP materials that are Conditions of the Marketing Authorisation prior to implementation, liaising with UK Marketing and Medical Affairs, as necessary
§ Liaise with the MHRA regarding the RMP measures relating to Teva marketed products, as necessary
§ Assist in the maintenance of the Risk Management Tracker for all licenced products.
§ Assist in the preparation of specific training on RMP measures (for specific products or in general), as required
§ Prepare and document pharmacovigilance training on product/therapeutic areas to relevant personnel.
Ad hoc safety issues/review:
§ Assist in preparing and reviewing actions and responses of ad hoc safety issues received internally and from Regulatory Authorities
§ Conduct Health Hazard Assessments for Teva products working closely with internal and external stakeholders.
§ Interact with Global Patient Safety and the European Qualified Person as necessary in the performance of this role.