Research Associate Pharmacovigilance
Lambda Therapeutics Limited
مجموع سنوات الخبرة :1 years, 10 أشهر
Data entry of regulatory cases received from Regulatory authority by uploading and importing XML & RTF files and analyzing received source document.
•Perform Duplicate search.
•Initiating received cases in database by creating safety IDs.
•Manage tracking of all cases received from regulatory authority.
•Weekly Reconciliation of regulatory cases with source of receipt.
•Receipt of cases from Eudravigilance.
•Preparation, revision, reviews of SOPs, WIs, Templates, guide and training document.
•Communication of urgent safety issues to Line manager and QPPV
•Ensure compliance (quality, procedure, regulations, timeliness consistency) with local regulations and company’s global Pharmacovigilance requirement.
• Deliver training to new joinee and team as per requirement.
• Work with the ICSR team leader to escalate issues or tasks outside the normal scope of work.
• Support line manager for timely submission of ICSR in order to achieve 100% regulatory compliance.
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