Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients. TRI is currently seeking a Safety and Pharmacovigilance Specialist to join our Bethesda, MD team.
- Perform various tasks in support of clinical research including adverse event analysis and processing, serious adverse event reconciliation, preparation of IND safety reports for submission to the FDA, safety document or data analysis, and clinical trial site support.
- Collecting accurate information from the site as required per the project and also responding to site queries.
- Review IND Annual Reports and CTA safety requirements.
- Provides medical evaluation of adverse event reports (depends on educational background and experience).
- Reviews experimental protocols, risk lists and informed consent documents regarding safety information.
- Analyze medical research data, review experimental protocols and summarize safety data (capability to analyze the safety data increases with experience).
- Other duties as assigned.
- M.D., D.O., PhD, Pharm D (or Master's level with direct safety experience) from an accredited institution with 0-2 years of experience
- Infectious disease and/or oncology subspecialty highly preferred
- Knowledge of GCP and ICH guidelines preferred
- Drug development/clinical trial experience essential
- Knowledge of CTC and/or Med DRA coding preferred
- Experience leading clinical and cross functional teams is a plus
- Must have excellent oral, written, presentation and computer skills
- 4 years Clinical Research or 2 years S & P or Non-Med 4 years S & P experience
- Knowledge of Microsoft Office
Submit resume and salary requirements to: Attn: AE, TRI, 6500 Rock Spring Dr, Suite 650, Bethesda, MD 20817, or fax to (301) ###-####, or email to ...@tech-res.com.
Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.