Experience

Qtech Solutions Inc.

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

• Drug Safety Associate (Training as Internship)

  • May 2017 - Present

  • Conducted MedDRA and WHO-DD coding of adverse events, suspected drugs, concomitant drugs and drug indications. • Performed quality check of adverse events reports. • Experience in case narration by reviewing, evaluating and summarizing the available information from the drug safety database and the specific source documents. • Triage and classification of Individual Case Safety Reports (ICSR) for report type, seriousness, causality, expectedness/labeling and reporting and prioritizing them according to the regulatory requirements. • Case Processing involving completion of full case information in the database, concluding in quality review to ensure accurateness. • Performed SAE Reconciliation between safety database and clinical database. • Case submission via MedWatch/CIOMS I and E2B forms. • Knowledge of safety databases Argus, ArisG (Adverse Event Reporting Software), AERS (Adverse Event Reporting System). • Knowledge of entering serious adverse events into the triage workflow in the Argus safety database. • Entry of safety data onto adverse events database and tracking systems. • Signal detection to find any indication of an unexpected drug safety problem and risk minimization activities to prevent or mitigate potential risks. • Review of adverse events for completeness, accuracy and appropriateness for expedited reporting. • Performing quality review of cases which includes review of source documents and ensuring that cases is accurate and that corrections to the case, if applicable, are incorporated. • Performing quality control activities to ensure complete and accurate case information has been entered into the drug safety database. • Knowledge of generating aggregate safety reports such as Annual Safety Reports (ASR), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Risk Management Plan (RMP), Risk Evaluation and Mitigation Strategies (REMS) and other reports from the drug safety database. Show less



ReeLabs Pvt. Ltd.

• India
• Hospitals and Health Care
• 100 - 200 Employee

• Research Associate

  • Jun 2014 - Dec 2014

  • Responsible for coordinating with patients and reference doctors with respect to stem cell therapy. • Review patient documents (informed consent, subject information sheet), clinical study protocol, case report forms as delegated by the project manager. • Reporting of adverse events/serious adverse events observed during the therapy. • Maintaining the adverse events reports. • Creating awareness about stem cell banking and therapy and handling of promotional activities. • Responsible for coordinating with patients and reference doctors with respect to stem cell therapy. • Review patient documents (informed consent, subject information sheet), clinical study protocol, case report forms as delegated by the project manager. • Reporting of adverse events/serious adverse events observed during the therapy. • Maintaining the adverse events reports. • Creating awareness about stem cell banking and therapy and handling of promotional activities.



Bittu Pharmaceuticals

• India

• Intern

  • May 2013 - Jun 2013

  • Expanded knowledge in production and quality control department which helped me understand the key skills required to make a product and dispense the drug and meet its compliance as per the FDA. • Analyzed and compiled the documentation part (batch manufacturing records, batch packaging records) under Assurance department which was necessary to meet the FDA approval. • Observed the manufacturing process of empty gelatin capsules in the production department. • Learned about the procedure and requirements for production of empty gelatin capsules and acquired an exposure to various other departments like Quality Assurance, Quality Control, Storage and Packaging. • Ensured proper separate storage of raw materials, in-process materials, rejected batch, finished products to prevent contamination Show less