Job Description:
Perform the review of quality systems, processes, and procedures for compliance with applicable regulatory regulations and pharmacovigilance guidelines and seek documentation approval from the CGSDCI President and relevant processes.Review internal controlled documents for compliance.Support internal and partner pharmacovigilance audits and inspections when needed.Responsible for the initiation and facilitation of internal training programs and shall provide recommendations to the team lead after training completion.Overall control of documentation and archiving system in a timely manner.Analyze quality deviations, identify root causes, and adjudicate Individual Case Safety Report (ICSR) corrections with corresponding issuance of Corrective action and preventive action, as appropriate.Drive continuous process improvement for Quality Assurance.Support to oversee the QMS-related processes for operations workflow.Support review of the Pharmacovigilance System Master File (PSMF).Validate Operations Key Performance Indicator (KPI) and Metrics data.Attend and contribute inputs in the QA Meetings.Train and mentor new resources.Establish work priorities and direction independently.Directly report to CGSDCI President the QA Pharmacovigilance deliverables.Perform assigned duties that drive business goals and corporate values.Qualifications:
Minimum of four (4) years relevant experience (case processing) required.Experience with computer applications including database management and pharmacovigilance systems (e.g., Argus) preferred.At least 1-2 years' experience in any GxP or highly regulated industry, preferably related to pharmacovigilance and/or clinical research.More than 6 years' professional experience and 2 years' experience in pharmacovigilance/clinical/community or research.Preferably with 2-3 years' People Management experience that will be of help to build and maintain positive relationships with management, peers, and direct reports.Willing to work in BGC, Taguig City for the duration of probationary employment. Work-from-home set-up may apply upon regularization.Your resume submitted to us will be reviewed by CGSDCI and Celltrion, Inc., a parent company located in Korea, for evaluation purposes on a need-to-know basis. We are committed to protecting and respecting your personal data and it will be treated in accordance with our internal data protection policies.
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