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Drug Safety Scientist
The Drug Safety Scientist will process Adverse Event (AE) cases received, Over-the-Counter (OTC), DSP to meet internal requirements and legal obligations on AE case processing, analysis, and reporting to Health Authorities.
Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs), conventions and company policies, databasing, as required, verifying assessments and processing of all initial and follow-up medical reports in the Global Safety Database (ARGUS). Perform duplicate searches Full Data Entry of Non-serious and Serious cases including literature, i.e., Adverse events, labs, and patient history from source documents, product coding, MedDRA coding in accordance with guidelines and conventions. Perform narrative writing. Generate and track requests for follow-up.
Communicate changes in assessments (serious vs. non-serious) to affiliates. Generate and track requests for follow-up. Draft clinical queries. Support literature searches and process assigned cases. Provide support in the review of basic QA (Annual Product Review Reports and Lack of Efficacy Reports) and US Periodic Safety reports.
Skills/Experience: Minimum 2 years of pharmaceutical or related industry experience and 1 year in Drug Safety strongly preferred; Experience requirements can be reduced with advanced education or equivalent clinical experience; Data entry experience required; OTC experience preferred.
Education: Bachelors degree or equivalent (degree in a medical or healthcare related field required - RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant).
Must be a HealthCare Professional to be qualified for this opportunity.
About IT&E International:
IT&E is a certified Veteran-owned niche provider of configurable validation and compliance services to the pharmaceutical, biotechnology and medical device industries.
Posted 4 years ago
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