Patient Safety Specialist At Sandoz Egypt
-Support management of Patient Safety operational processes at Country Organization in ensuring compliance with global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance.
-Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.
-Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
-Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments.
-Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
-Interact and exchange relevant safety information with Local Health Authorities, Patient Safety associates, other functional groups and third party contractor, if applicable.
-Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
-Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
-Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
-Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
-Management and maintenance of all relevant Patient Safety databases.
-Ensure that relevant local literature articles are screened as appropriate.
-Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to Local Health Authorities, development and implementation of corrective action(s) as needed.
-Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
-Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
-Manage and maintain efficient Patient Safety filing and archive system.
-Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization is conducting the trial, review the contract (SSW), train the Contract Research Organization associates responsible from the trial
-Drives the local execution of the Risk Management Plans for all products
-Ensures training on Risk Management Plans principles and product specifics of Country Organization staff involved in the implementation.
-Supports the Drug Safety Responsible in the timely and compliant execution locally of the Pharmacovigilance activities defined in the Risk Management Plans.
-Liaises with the other departments in the Country Organization such as Clinical Research Operations, Medical, Regulatory Affairs or Sales/Marketing to ensure alignment of all local functions in support of the Risk Management Plans
-Liaises with Sales/Marketing to ensure implementation of educational materials
-Liaises with Local Regulatory Affairs to ensure tracking of status of the Risk Management Plans commitments implemented locally
-Pharmacist with 3-5 years of experience in Health Care Sciences Professional or equivalent education, training and experience
-Knowledge of national and international regulations for pharmacovigilance
-Knowledge of pharmacological and medical terminology.