The Eijkman-Oxford Clinical Research Unit (EOCRU) in Jakarta opened in 2008 with the signing of a memorandum of understanding between the Eijkman Institute for Molecular Biology and the University of Oxford, to conduct collaborative research on infectious diseases impacting the health of Indonesians and residents of other Southeast Asian nations. University of Oxford also has a partnership (MoU) with Universitas Indonesia, and they jointly established the Universities of Indonesia and Oxford Clinical Research Laboratory (IOCRL) which is a facility dedicated to supporting collaborative clinical research between the universities. EOCRU is also part of the Oxford Tropical Network with research units in Africa, Asia and UK, and operates under the auspices of the Oxford University Clinical Research Unit in Vietnam.
Clinical trials of chemotherapeutics, diagnostics and vaccines for tropical infections of public health importance in Indonesia, principally malaria, tuberculosis, antimicrobial resistance, and other emerging and neglected tropical diseases, form the core of EOCRU’s activities, with associated epidemiological, laboratory, and clinical research. EOCRU aims to have a positive and significant impact on the prevention, diagnosis and treatment of infectious diseases to improve patient care in Indonesia and the region. This is being achieved via an expanding long-term research programme with our local hosts and partners, contributions to research training, and public engagement with science. Current EOCRU core staff includes Oxford-employed international scientists, Indonesian scientists, administrative and finance support staff, and clinical trials support staff.
In conducting their work in Indonesia, EOCRU is assisted by Alliance for Emerging and Re-emerging Disease Threats in Asia Foundation (ALERTAsia), a local foundation assisting in research grant management and capacity building for local researchers.
Through ALERTAsia, we are seeking a qualified and experienced Pharmacovigilance Manager.
Job Descriptions:
Pharmacovigilance Compliance
1. Ensure timely notification of safety-related issues, in line with institutional and relevant legislative statutes and regulations.
2. Data entry into data capture software and databases Support the ongoing monitoring of study conduct to ensure compliance with study safety SOPs via site visits and study metrics.
3. Conduct AE/SAE reconciliation of study databases.
4. Contribute with analysing data and the preparation of clinical study reports, publications, final reports and presentation.
5. Prepare and/or contribute to protocol-specific safety related documentation, including protocol-specific, safety-related plans (e.g., Safety Management Plans (SMPs), reconciliation plans), forms (e.g., SAE Report Forms and Form Completion Guidelines, Pregnancy Notification and Outcome Forms), convention documents, and other documentation.
6. Generate monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
7. Manage the creation and provision of data (e.g., line listings, summary tabulations, data transfer files) to Data Management for clinical and safety database SAE reconciliation, to Safety Committees/Drug Safety.
8. Monitoring Boards for protocol-specific safety oversight, and to the clinical team for the Trial Master File.
9. Participate in training of clinical pharmacovigilance staff, identifying training needs, developing and maintaining training documents and curricula, and conducting training.
10. Participate in the development and continuous improvement of Standard Operating Procedures (SOP), Work Instructions (WIs), and other documents associated with clinical pharmacovigilance and client management.
11. Maintain a comprehensive understanding of guidance documents and directives associated with pre-market clinical pharmacovigilance and reporting.
12. Make decisions consistent with company guidelines and policies.
13. Communicate needs of the department and provide solutions to pharmacovigilance management responsible for cascading relevant information from internal and external meetings to pharmacovigilance management and appropriate colleagues.
14. Build and maintain good relationships across functional units and Site Study Teams.
Patients’ Safety Strategy
15. Maintain oversight on the patients ‘safety aspect of clinical trial and/or data generation activities in EOCRU.
16. Ensure standardized systems and processes are in place to enable safety monitoring, including identification, recording, reporting and analysis of safety information and risk management across clinical trials and projects conducted by EOCRU.
17. Develop and maintain patients’ safety-related systems and processes across clinical trials and projects conducted by EOCRU.
18. Keep abreast of the latest regulations and requirements on patients’ safety in clinical trial and ensure compliance to such regulations is met.
19. Provide strategic insight in improving clinical trial quality across the organization and approaches to ensure the rights, safety and well-being of clinical trial participants.
Clinical Trial Conduct
20. Perform pre-trial Protocol Risk Assessments and develop and implement risk mitigation measures with the clinical trial team.
21. Advise on information that should be provided to prospective trial participants, including informed consent, with particular attention for vulnerable populations.
22. Develop and maintain patient safety-related procedures as part of risk mitigation measure in compliance with the current local standard of care, clinical trial protocol, and national and international regulations.
23. Develop and conduct training on patients’ safety-related procedures to relevant study personnel.
24. Ensure all field/site physicians received proper medical trainings required by the study protocols.
25. Oversee the implementation of patients’ safety related procedures across EOCRU clinical trials related to participant screening, recruitment and follow-up.
26. Develop trial-specific policies on feeding back findings and actions related to incidents or health-related events in a clinical trial.
27. Perform medical review of individual safety cases (providing medical expertise and judgement).
28. Ensures the accuracy and timeliness of clinical trial-related adverse event reports, including but not limited to seriousness, expectedness, safety narratives, and causality statements.
29. Review and provide clinical safety-related input to clinical study reports, publications, ethics committee/regulatory inquiries and/or renewal documentation submitted to regulatory agencies, as required.
Quality
30. Conduct internal clinical trial review and/or audits to ensure patient safety procedures are adhered to and compliance is met.
31. Conduct Root Cause Analysis (RCA) in response to non-compliance and/or incidents of health-related events and develop Corrective and Preventive Actions (CAPA) with the respective study team.
Qualifications
Education and Experience
· Medical Doctor (Preferred) or MSc/PhD in Life Sciences.
· Minimum of 5 years or 7-10 years (senior) of clinical trial, pharmacovigilance and/or drug development experience.
· At least 3 years or 5 years (senior) of clinical safety experience with clear evidence of delivery.
· High level of medical competence and knowledge of disease areas and treatment.
· Excellent English scientific writing and communication skills.
· Ability to work effectively in matrix environment.
Required Knowledge and Abilities
· Good Clinical Practice (GCP).
· Good Pharmacovigilance Practice (GVP).
· Relevant local and global Clinical Trial Regulations.
· Familiarity with local diseases guidelines and patient management standards.
· Preferably certified in ACLS, ECG and ATLS.
· Procedural document writing and management.
· Risk Management and Mitigation, including Root Cause Analysis and CAPA development.
· Organization skills.
· Interpersonal skills and problem-solving capabilities.
· Strategic agility.
· Strong verbal and written communications skills.
· Learning agility and ‘scalability’ to take on additional responsibility.
Benefits
The selected candidate will receive a one-year contract with possible extension, and remuneration package that includes annual leave, sick leave, THR, compensation money, optional private medical cover, BPJS Kesehatan, and not to mention fully paid income tax and BPJS Ketenagakerjaan (JAMSOSTEK). The salary shall be competitive and dependent upon qualifications and salary history.
Duty Station
Jakarta
Salary Offer:
Rp. 27.000.000,-
How to Apply
(Please make sure you submit complete requirements to the application)
Interested candidates are invited to send your Cover Letter and Curriculum Vitae by email to hro@alertasia.org with subject line EOCRU_PM_(Applicant Name)
Please submit your application not later than Friday, 31 March 2022
Thank you.
