Overview Piper Companies is looking for a Safety & Pharmacovigilance Specialist I to join a clinical research organization located in Bethesda, MD. Responsibilities Ensure compliance with FDA, WHO, and global regulatory standards for adverse event reporting Manage consistent and timely processing of adverse event reports Conduct medical evaluations of reported adverse events Support clinical research activities for both marketed and investigational drugs, including adverse event reporting and analysis Maintain and update toxicity summary tables for investigational agents Perform literature reviews and safety data analysis Prepare IND safety reports and assist with NDA safety updates, investigator communications, and product labeling Review experimental protocols and informed consent documents; contribute to safety-related presentations Qualifications Familiarity with GCP and ICH guidelines; experience in drug development and clinical trials required Knowledge of safety databases and MedDRA coding preferred Experience leading clinical or cross-functional teams is a plus Strong oral, written, presentation, and computer skills Minimum of 2 years in academic, pharmaceutical, or biotech settings Compensation and Benefits Rate Range: $70,000-$100,00+ (dependent on experience) Comprehensive Benefit Package: Medical/Dental/Vision, 401K, Sick Leave as Required by Law This job is open for applications on September 18, 2025. Applications will be accepted at least 30 days from the posting date. Keywords Safety & Pharmacovigilance Adverse Event Reporting Serious Adverse Event Reconciliation IND Safety Reports NDA Safety Updates Clinical Trial Support FDA Regulations WHO Guidelines Global Regulatory Compliance GCP ICH MedDRA Coding Safety Data Analysis Literature Review Toxicity Summary Tables Investigator Communication Protocol Review Informed Consent Documents Drug Development Clinical Research Biotech Pharmaceutical Safety Databases Signal Detection Risk Management Plans Case Narrative Writing Regulatory Submissions Benefit-Risk Assessment Safety Surveillance Pharmacovigilance Systems #J-18808-Ljbffr Piper Companies
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