Overview Piper Companies is seeking a Safety & Pharmacovigilance (S&P) Specialist to join a dynamic team in Bethesda, MD . This role is ideal for professionals with a strong background in clinical research and drug safety who are passionate about ensuring regulatory compliance and supporting the development of investigational and marketed drugs. Responsibilities Ensure compliance with TRI SOPs, FDA, WHO, and global regulations for adverse event reporting. Develop and manage uniform, timely processing of adverse event reports. Provide medical evaluation of adverse event reports. Support clinical research activities including reporting, collecting, and sharing adverse event data. Maintain and update toxicity summary tables for investigational agents. Conduct literature searches related to drug safety and efficacy. Analyze and process adverse events; reconcile serious adverse events. Prepare IND safety reports for FDA submission and conduct safety data analysis. Provide clinical trial site support and manage safety communications. Assist in preparing NDA safety updates, IND safety reports, investigator communications, product labeling, and other regulatory documents. Review experimental protocols and informed consent documents; prepare and edit safety-related presentations. Qualifications Master’s Degree required. Minimum 2 years of experience in academic, pharmaceutical, or biotech industry. Strong knowledge of GCP and ICH guidelines; clinical trial experience essential. Familiarity with safety databases and MedDRA coding preferred. Experience leading clinical and cross-functional teams is a plus. Excellent oral, written, presentation, and computer skills. Compensation Salary Range: $70,000.00 – $85,000.00 annually, depending on experience and certifications Comprehensive Benefits: CIGNA Medical, Dental, Vision; 401K through ADP This job opens for applications on 9/17/2025. Applications for this job will be accepted for at least 30 days from the posting date. #J-18808-Ljbffr Piper Companies
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