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
Job Title: Patient Safety Specialist
- 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
Required Expertise / Competence
- Process management
- Understanding of National Health Care, regulatory environment of drug P&R and Listing processes Pharmacovigilance Healthcare professional with
- Operations Management and Execution
- Collaborating across boundaries Functional Breadth
BSc Medicine, B. Pharmacy, BSc Nursing, BSc Physician Assistantship or any other healthcare professional degree recognized by Ghana Health Authority