Quality Control Specialist
Cactus Communications
مجموع سنوات الخبرة :6 years, 9 أشهر
• Review regulatory documents (e.g., CERs, CEPs, protocols, amendments, IBs, CSRs, eCTD, summary documents, appendices, and clinical trial disclosures) for data accuracy against source data and consistency between the document text and the in-text tables.
• Check for grammar, syntax, style, and compliance with style guides, regulatory guidelines, and publishing requirements.
• Check documents generated by writers for data errors by checking annotated references.
• Check documents generated by writers for fact errors (discrepancy between source data and document, discrepancy within the text, discrepancy
between figures/tables and text).
• Be responsible for the accuracy of data (numerical and otherwise) in the documents/projects assigned.
• Ensure timely delivery of documents
Multitask which includes pulling up various vigilance submission reports from the IBM Cognos analytics platform daily.
Reporting adverse events of client products to respective health authorities. Also working on Foreign Line Listings.
Experienced in drafting safety narratives.
Fully responsible for all local country submissions and medical device reports for all countries in scope including cover letters.
Process data onto submission forms and submit the required reportable complaint or adverse event to Health Authority via online portals or e-mail. Understand the specific regulation on the process to submit complaints and adverse events to the Health Authority.
Interact with Health Authorities in various inquiries related to device complaints, adverse events, and submissions.
Lead the training and mentoring of juniors.
Worked for Quality Control of Clinical Documents (QCCD).
Performed full review for high-end documents like Protocols, Amended Protocols, DSURs, ICFs, Narratives, and IBs for data accuracy against source data and consistency between the document text and the in-text tables.
Performed part review for a few CSRs. Trained on IMPD reviews.
Core areas of competency in performing systemic reviews.
Performed Literature review for Protocols, Amended Protocols, IBs, and CSRs.
QC/review of all written output from the operations team as required.
Lead the training and mentoring of new joiners.
Group of Institution
Pharmacy &
Group of Institution
Group of Institution