Patient Safety Specialist

Major Accountabilities

• Adverse Event Management: Oversee the collection, processing, documentation, and reporting of all adverse event reports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Programs (POPs), literature, and spontaneous reports.
• Data Accuracy: Transcribe, translate, and enter data from source documents into safety systems accurately and consistently, ensuring quality and timeliness.
• Regulatory Reporting: Manage the submission and distribution of safety reports and updates (e.g., SAE, SUSAR, PSUR, DSUR) to Local Health Authorities (LHA) and clinical operations.
• Compliance & Procedures: Develop and implement local procedures to ensure compliance with global Patient Safety standards and national requirements.
• Cross-Departmental Collaboration: Partner with Medical Affairs, Marketing, and Patient Engagement to ensure safety data collection in various initiatives follows vigilance requirements.
• Contractual Oversight: Manage vigilance clauses in local agreements and ensure compliance with pharmacovigilance commitments in contracts.
• Reconciliation: Perform reconciliation with Medical Information, Quality Assurance, and third-party contractors for potential adverse events from various sources.
• Safety Databases: Maintain relevant local Patient Safety databases and screen local literature articles for safety data.
• KPI Reporting: Prepare and submit KPI reports on compliance, identifying root causes for any late reporting and implementing corrective actions.
• Training: Develop training materials and conduct safety training for associates and third-party contractors.
• Audit & Inspection Support: Support internal audits and Health Authority inspections, including the implementation of CAPA plans.
• Regional Responsibility: Act as the Deputy QPPV for Kenya, Burundi, Djibouti, Eritrea, Rwanda, and Tanzania.

Key Performance Indicators

• Adherence to Novartis policy and guidelines.
• Operational risk mitigation and positive audit/inspection findings.
• Quality and timely reporting of KPI and safety reports.
• Internal and external customer satisfaction.

Qualifications and Requirements

• Education: A degree in Care Sciences (e.g., Nurse, Pharmacist), a Life Science degree, or equivalent training and experience.
• General Qualification: BA/BSc/HND level qualification.

How to Apply

Interested and qualified candidates should apply online through the Novartis career portal. Click on the following link to proceed: Apply to Novartis.