Patient Safety Specialist at Human Capital Synergies Africa Ltd

Our Client, a global healthcare Company seeks to recruit a Patient Safety Specialist.

The Job holder will support management of Patient Safety operational processes at Country Organization in ensuring compliance with the Company’s global/local procedures, national and international regulations/ standards/guidelines for pharmacovigilance of the group, marketed and investigational products (drugs and devices).

Reports to: Patient Safety Group Manager

Roles and Responsibilities

1. Manage  collection,  processing,  documentation,  reporting  and  follow-up  of  all  adverse  event reports for all Company 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.
2. 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.
3. Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
4. Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.
5. Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.
6. Develop,  update  and  implement  local  procedures  to  ensure compliance  with  Patient  Safety global procedures and national requirements.
7. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
8. 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.
9. Management and maintenance of all relevant Patient Safety databases.
10. Ensure that relevant local literature articles are screened as appropriate.
11. 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.
12. 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.
13. Ensure  support  for  and  close-out  of  audits,  corrective action  plan,  investigation  and  Health
14. Authority inspections.
15. Ensure training and oversight of staff, as applicable.
16. Manage and maintain efficient Patient Safety filing and archive system.
17. Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Re- search Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible for the trial
18. Drive all Patient Oriented Programs pharmacovigilance related activities (case processing, submission to local Health Authority, conduct follow-ups, train stakeholders involved in POPs)
19. And any other agreed tasks assigned by manager.

Education

2 years experience in Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience

Experience/Professional Requirement

1. Knowledge of national and international regulations for pharmacovigilance
2. Knowledge of pharmacological and medical terminology.
3. Excellent  communications,  interpersonal  and  negotiation skills
4. Quality and focus oriented
5. Proficiency in MS Office applications