To secure a responsible and challenging position in the field of drug safety and pharmacovigilance.
Experienced medical professional focused on drug safety and pharmacovigilance with expertise in case processing using Oracle Argus Safety 8.0, coding cases using MedDRA 23.1 and Confidential drug coding. Proficient in performing causality assessment, writing case summaries and assisting in preparing reports. High - energy result-driven dedicated, experienced professional with strong communications and problem-solving skills.
- Experienced in Oracle Argus Drug Safety database (Version 8.0) and MedDRA (Version 23.1)
- Understanding of ICH-GCP and HIPAA guidelines and GVP Guidelines
- Experienced in Corrective and Preventative Action (CAPA) in analytical roles
- Knowledge of 21 Code of Federal Regulation parts 11, 50, 54, 56, 312
- Capable of Serious Adverse Event (SAE) reporting and Individual Case Safety Reporting (ICSR)
- Microsoft Office (Word, Excel, Power Point, Outlook), Blackboard, Canvas
Confidential, Edison, NJ
Drug Safety Associate Intern
- Monitoring of drug safety inbox. Perform Case Processing, generating case receipt number, Case Triage and process adverse event reports according to applicable regulations, guidelines, SOPs and project requirements.
- Ensure a duplicate check using Global Safety Database (ARGUS) for all ICSR (Individual Case Safety reports) for existing case file.
- Perform Case book in and Data Entry.
- Assessment of Case Reports for Seriousness, Causality and Expectedness.
- Prioritizing the adverse event reports processing base on the ICH dates.
- Perform Safety Data entry in the database, Coding relevant Medical Terminology, Writing Narratives for MedWatch (FDA 3500A) and CIOMS forms for domestic and international cases, Generating queries pertinent to the case, Evaluation (QC Check).
- Coding of medical history, drugs and reported adverse event terms in safety database using medical dictionaries like MedDRA and Confidential .
- Filing PQCs (Product Quality Complaints) associated with adverse events.
- Processing of collected data in company databases as per applicable standards, regulations and guidelines. Ensure data accuracy and consistency.
- Setting up follow-up. Produce Clinical Safety Queries as needed for clarification of reports.
- Case clean-up activities, as necessary, including case maintaining inspection readiness.
Confidential, Jersey City, NJ
- Developing and implementing daily and unit lesson plans for class and laboratory.
- Administering tests and evaluations, and analyzing student performance using Blackboard.
- Managing and supervising A&P laboratory.
- Responsibilities include academic advising of students, participation in school committees and activities, and supervision of projects.
Confidential, South Plainfield, NJ
Science Class Teacher
- Developing and implementing daily and unit lesson plans for class, administering tests and evaluations, and analyzing student performance.
- Providing support in curriculum development and textbook selection activities.
- Recommending improvements to current instructional methodologies.
- Participating in campus meetings and educational committees.
- Assisting in resolving academic issues promptly. Adhering to academic policies all times.