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Senior Patient Safety Specialist & Local Safety Responsible Tunisia
REQ-10035193 Jan 13, 2025 Tunisia
Summary
-Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
About the Role
Major accountabilities:
To support 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. Work 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. Management and maintenance 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)
Tunisia Local Safety responsible: act as single point of contact with the National Health Au-thority in Tunisia on a 24-hour basis regarding pharmacovigilance matters and as the interloc-utor dur-ing pharmacovigilance inspections. Ensure all LSR responsibilities as defined by local regulations as follows:
Have access to all relevant information and any updates related to the PV system: PSMF, corrective and preventive actions (CAPA) at the end of each audit of the PV system.
Contribute to risk management plans and the preparation of regulatory actions in re-sponse to potential safety issues.
Make changes to the PV system or trigger an audit if necessary.
Review of security documents (PSUR, RMP) before submission to HA.
Communicate with the QPPV office if necessary regarding the information contained in the PSMF related to Tunisia country.
Elaborate the PSSF for Tunisia and keep it up to date.
Notify the CNPV and DMP of the PSMF and PSSF location and any changes to that location.
Submit the LSR’s and his deputy contact information to the CNPV and DPM and inform of any change made.
Ensures that the submission of adverse events is done in accordance with Tunisia regula-tions.Collaborate with the CNPV in the evaluation
Key performance indicators:
Adherence to Novartis policy and guidelines -Project and stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections
Minimum Requirements:
Medical or pharmacy degree and a minimum of 2 years experience in pharmacovigilance.
Work Experience:
Functional Breadth. Collaborating across boundaries. Operations Management and Execution.
Skills:
Databases. Employee Training. Filing (Documents). Pharmacovigilance. Reporting. Safety Science.
Languages :
English.
Why Novartis:
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Development Innovative Medicines Tunisia Tunis TNP0 (FCRS = CH024) Novartis Pharma Services Research & Development Full time Regular No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
REQ-10035193
Senior Patient Safety Specialist & Local Safety Responsible Tunisia
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