לוח אפשרויות קריירה - הדרך החכמה להייטק

The opportunity
– Core member of the safety team and is responsible for performing pharmacovigilance activities within the North American PV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialist and Pharmacovigilance Managers/Director to receive and review adverse event information for pre and postmarketed products- Should serve as a liaison with other Teva business units and function as a resource to the team. – Review and confirm that accurate written records of all PV related activities are created, organized and maintained in compliance with all applicable global and local Standard Operating Procedures (SOPs), local Work Instructions (WIs) and ensure that they are up to date as required by regulationsHow you’ll spend your day
-Assist and co-ordinate in the preparation of Risk Management Plans (with associated Risk Mitigation Strategies) as per the requirement of Health Canada.- Responsible for handling local labelling updates (from the CCSI update to submission of safety variation) for all Teva medicinal products taking into consideration local regulatory timelines.- Review and submit Periodic Safety Update Reports (PSURs) and the Canadian Annual Summary Report (ASRs) to Health Canada according to their regulations and guidance.- Oversight of ADR reports downloaded from the Health Canada Vigilance Adverse Reaction Online Database and to ensure all Health Canada requirements are met. – Assist and co-ordinate in preparation of Health Hazard Assessment on request. – Other essential duties include drafting pharmacovigilance agendas and meeting minutes, accurately archiving pharmacovigilance documents- Participate in Pharmacovigilance audits and inspections as needed- Contributes to process improvements and assist with CAPA review.- Responsible to complete all training and SOP/WI reviews in a timely manner- Creates and/or updates SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures of make them more efficient- Support the manager in training new hires in PV on systems and processes relating to pharmacovigilance activities-Participates in Pharmacovigilance local activities with case and workflow management- Interfaces with other departments to facilitate information exchange as needed- Responsible for leading local/regional projects when assigned- Any other activities assigned by the Manager.