- Medical professional with experience as a physician and epidemiologist, completing a drug safety internship.
- Experienced in case processing using Oracle Argus Safety 8.0, coding cases using MedDRA 22.0 and WHO drug coding.
- Proficient in performing causality assessment, writing medical case summaries, and assisting in preparing reports for FDA, EMA and EU submissions.
- A well - rounded individual capable of working independently and as part of diverse teams.
- Proficient in Oracle Argus Safety 8.0.
- Expert in coding using MedDRA, WHO Drug dictionary.
- Experienced in Individual Case Safety Report (ICSR).
- Thorough understanding of FDA, EMA regulations and ICH-GCP guidelines.
- Proficient in Microsoft Office including Word, Excel, and PowerPoint.
Drug Safety and Pharmacovigilance Intern
- Triaged the incoming cases to maintain daily workflows.
- Performed data entry in the Argus Safety database by coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, and ensuring that the case processing is done accordingly.
- Processed cases using Argus Safety database, including quality review to ensure accuracy and completeness within the specified timelines.
- Performed duplicate checks in the Global Safety Database by using different permutations and combinations of available case information.
- Created electronic case reports for new cases.
- Assessed case reports for case validation, seriousness, causality, and expectedness.
- Performed Causality assessment using Global Introspection method.
- Set up follow up letter to the reporter for further case follow up and assisted in reporting the case to the respective regulatory agencies.
Primary Care Clinical Volunteer
- Obtained relevant medical information from patient records including case reports and lab findings.
- Wrote case narratives and presented the cases including all previous medical records.
- Maintained all previous medical records and provided supportive materials to every patient.
- Monitored patients for any adverse events (AE).
- Ensured compliance with HIPAA and OSHA regulations.
- Provided patient care to both inpatients and outpatients.
- Mentored and supervised new residents on how to properly design and draft their research theses.
- Provided compassionate care to outpatients at this leading medical clinic.
- Educated patients about how to maintain and improve their health.
- Diagnosed and treated patients, and referred select patients to see specialists.