Summary

Location: Cairo, Egypt #LI-Hybrid

About the Role:

As a Patient Safety Specialist, you will be responsible for monitoring and auditing the company's drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participating in the resolution of any legal liability and in complying with government regulations. Ensuring accurate receipt, maintenance and assessment against product labeling. Reporting events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May be providing trending and safety signal detection and assessment. Supporting all clinical trial activity and post marketing.

• Support in the management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products.
• Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
• Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
• Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments.
• Collaborate with other local/global PV associates to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with LHA, PV associates, other functional groups and third-party contractor, if applicable.
• Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization.
• Develop, update and implement local procedures to ensure compliance with PVO global procedures and national requirements. Manage and maintain all relevant assigned PVO databases, if applicable.
• Develop and update training materials for pharmacovigilance -Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections.
• Provide timely, relevant information to trial coordinators, CRAs and other Novartis staff -Distribution of marketing samples (where applicable)

• Pharmacist or MD is a must.
• 1-2 years of relevant experience (e.g., Patient Safety, Medical Affairs, QA, PSP, Regulatory).
• A proven experience contributing to different projects if experience is in Commercial.
• Proficient in English Language.
• Advanced proficiency in Microsoft Office (e.g. MS Word, MS PowerPoint, MS Excel, MS Outlook).

• Databases.
• Employee Training.
• Filing (Documents).
• Pharmacovigilance.
• Reporting.
• Safety Science.

• Arabic.
• English.