Drug Safety Specialist

Our Strength Is Our People. Passion. Principles. Perspective. At Watson, they're the traits that drive our growth and we apply them to every project and product. If you bring these qualities to your work, then we'd like you to consider joining our team.Receives, processess, and evaluates adverse events and product complaints and interacts with Regulatory Affairs on issues pertaining to submission of appropriate reports to FDA and with Quality department on issues pertaining to quality investigation requests.Appropriately maintains complaint files for adverse event reports and product complaints, both in electronic complaint database and in hard-copy folders.Assists in generating and evaluating required expedited and periodic reports for submission to FDA, which includes, but not limited to, apropriate MedDRA coding of adverse event terms and compiling narrative/medical assessment of 15-day expedited reports as part of periodic reports.Interprets and applies current department SOPs and FDA and international guidelines and regulations as they pertain to drug safety.Bring serious or potentially serious adverse and event complaints and any Drug Safety-related issues to the attention of management and/or Drug Safety Review Committee as necessary and appropriate.Provides appropriate on-the-job training/mentoring for appropriate staff as assigned.Participates in professional and department meetings providing medical input and recommendations for improvement.Qualifications
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and international regulations and guidances.Pharmaceutical and pharmacovigilance principles, practices and their application.Medical terminology and treatment modalities.Pharmacology principles, theory and their application.Quality assurance principles.Watson offers competitive medical and dental benefits, including vision, 401(k) and educational reimbursement.Watson Pharmaceuticals, Inc. is an Equal Opportunity Employer M/F/D/V. We value the benefits of diversity.Apply Online Now!
REQUIREMENTS
Drug Safety