Your Duties The Role
- You will manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all the Organization’s products (including clinical trials, non-intervention studies, Patient-Oriented Programs, etc.)
- You will manage submission of safety reports to Local Health Authorities and/or other Country Organization Departments
- You will work with other local/global Patient Safety Associates to ensure accurate evaluation of safety data.
- You will interact and exchange relevant safety information with local health authorities, Patient Safety associates, other functional groups and a third-party contractor if applicable.
- You will survey and monitor national pharmacovigilance regulations and provide updates to global safety organization.
- You will develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.
- You will input, review and approve program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
- You will 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.
- You will manage and maintain relevant Patient Safety databases.
- You will ensure that relevant local literature articles are screened as appropriate.
- You will 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.
- You will 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.
- You will ensure support for, and close-out of audits, corrective action plan, investigation and Health Authority inspections.
- You will ensure training and oversight of staff, as applicable.
- You will manage and maintain an efficient Patient Safety filing and archive system.
- You will review all Phase IV Clinical Trials and NIS protocol’s safety sections and if a Contract Research Organization is conducting the trial, review the contract (SSW), train the CRO associates responsible for the trial
- You will drive all Patient-Oriented Programs pharmacovigilance related activities
- You will also perform any other agreed tasks assigned by the manager
Source: Vacancies in Ghana
