Experience

ACX International

• Singapore
• Information Technology & Services
• 1 - 100 Employee

• Cryptocurrency specialist

  • Nov 2021 - Present



ClinChoice

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Specialist

  • Jun 2019 - Aug 2022

  • Preparation of new application for marketing authorization/renewal/variation of medicinal products, medical devices, cosmetics, food supplements for regulatory submission.• Responsibility over compilation and binding of the regulatory dossiers for new application of marketing authorization/renewal/variation.• Submission of products registration application .• Establishment of a specific project file and management of archiving files.• Performing literature review of safety, efficacy and quality data.• Responsibility over creation, review, conversion, content proofreading of information and linguistic aspects for CCDS, SPC, patient information leaflet, inner and outer packaging in accordance with requirements of regulatory authorities per the Client country.• Specifying storage, labelling and packaging requirements.

• Pharmacovigilance ICSR

  • Feb 2019 - Aug 2022

  FMD K&L-Yerevan, Armenia Quality Reviewer for ICSR-Feb/2018-present• Verify the data entry done at the CP step as per the inhouse/client SOP's/guidelines to ensure the quality.• To review the source document for valid case criteria, follow-up information and information adequacy.• Review of data entered using source documents and information of all serious and non-serious events• Verify MedDRA Coding, medical history, events, laboratory details using the latest MedDRA version.• Verify Product and concomitant medication details.• Check the causality and labeling assessment. • Check the narrative for accuracy and consistency. • Responsible for completing the QR activities in safety database within the stipulated time. • Provide feedback to case processors on the errors/discrepancy noted. • Ensure timely and appropriate regulatory submissions.• Update the assigned trackers. • Participate in Process Improvement Initiatives to keep up the Quality and Compliance score.• Work closely with Lead/Project Manager for daily operations.• Assist with related administrative and procedural activities as and when required.• Assists in the training of other case processing personals.• Update and interact with the client on a regular basis. • Mentoring for new joinees in the team.



Tristar Transindo

• Indonesia
• Truck Transportation
• 1 - 100 Employee

• Broker agent

  • Sep 2018 - Jan 2019