In conducting their work in Indonesia, OUCRU ID 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 Clinical Safety Associate to be responsible for compliance, strategy, conduct and quality of the clinical trial/research management that is assigned to him/her. The worksite is the Faculty of Medicine Universitas Indonesia campus at Salemba in Central Jakarta.
Roles and Responsibilities
Pharmacovigilance Compliance:
· Ensure timely notification of safety-related issues, in line with institutional and relevant legislative statutes and regulations
· 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
· Conduct AE/SAE reconciliation of study databases
· Contribute with analysing data and the preparation of clinical study reports, publications, final reports and presentation
· 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.
· Generate monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
· 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.
· Monitoring Boards for protocol-specific safety oversight, and to the clinical team for the Trial Master File.
· Participate in training of clinical pharmacovigilance staff, identifying training needs, developing and maintaining training documents and curricula, and conducting training.
· 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.
· Maintain a comprehensive understanding of guidance documents and directives associated with pre-market clinical pharmacovigilance and reporting.
· Make decisions consistent with company guidelines and policies.
· 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.
· Build and maintain good relationships across functional units and Site Study Teams.
Patients' Safety Strategy:
· Maintain oversight on the patients 'safety aspect of clinical trial and/or data generation activities in OUCRU ID
· 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 OUCRU ID.
· Develop and maintain patients' safety-related systems and processes across clinical trials and projects conducted by OUCRU ID.
· Keep abreast of the latest regulations and requirements on patients' safety in clinical trial and ensure compliance to such regulations is met.
· 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:
· Perform pre-trial Protocol Risk Assessments, and develop and implement risk mitigation measures with the clinical trial team
· Advise on information that should be provided to prospective trial participants, including informed consent, with particular attention for vulnerable populations
· 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
· Develop and conduct training on patients' safety-related procedures to relevant study personnel.
· Ensure all field/site physicians received proper medical trainings required by the study protocols.
· Oversee the implementation of patients' safety related procedures across OUCRU ID clinical trials related to participant screening, recruitment and follow-up.
· Develop trial-specific policies on feeding back findings and actions related to incidents or health-related events in a clinical trial
· Perform medical review of individual safety cases (providing medical expertise and judgement)
· Ensures the accuracy and timeliness of clinical trial-related adverse event reports, including but not limited to seriousness, expectedness, safety narratives, and causality statements
· 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:
· Conduct internal clinical trial review and/or audits to ensure patient safety procedures are adhered to and compliance is met.
· 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 2 years of clinical trial, pharmacovigilance and/or drug development experience.
· At least 1 years 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 initially receive a 12 months' contract with a possibility to receive a contract extension. 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.
The successful candidate will work in a dynamic team of clinicians, academics, scientists and research support teams from diverse renowned, international centres.
How to Apply:
Application requirements (Cover Letter, CV, three names and address of professional referees, and your salary history) should be sent via email to: hro@alertasia.org . Please quote the reference "OUCRU ID CSA_[Your Name]" on your email subject.
Please submit your application no later than Saturday, 29 June 2024.
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