Our client, a global healthcare leader is looking for a well-organized and a proactive Patient Safety Intern to help with their operations in Ghana.
To support the management of Patient Safety operational processes at Country Organization in ensuring compliance with the organizations global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of the organization, marketed and investigational products (drugs and devices).
Roles & Responsibilities
- Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Organizations 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 (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) 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 LHA, Patient Safety associates, other functional groups and third-party contractor, if applicable.
- Survey and monitor national pharmacovigilance regulations and provide an update to the 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 LHA, 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.
- Ensure training and oversight of staff, as applicable.
- 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 (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible for the trial
- Drive all Patient-Oriented Programs pharmacovigilance related activities (case processing, submission to local Health Authority, conduct follow-ups, train stakeholders involved in POPs)
- And any other agreed tasks assigned by manager.
Key Performance Indicators
- Quality and timely reporting of KPI and safety reports/updates
- No critical findings in audits or inspections.
- Customer feedback