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
Company Description Thorpe Commercial Capital provides commercial real estate debt and equity finance to owners and investors across all property types nationwide. The best terms for our clients are not advertised they are negotiated through having significant long...
...substantiate incentive applications and refund claims. Communicates and interacts with clients and external contacts at Regulatory and Taxing Authorities. Value: # Researches and analyzes state severance tax issues and communicates to management. # Gathers data,...
...Career Move? Join Our HVAC Maintenance and Sales Team! Are you a dynamic professional... ...Sales Specialist. This unique role blends technical expertise with sales acumen, offering an... ...ready to take your HVAC career to the next level, apply now and join our team of dedicated...
...Resorts Position Overview: Supports the Human Resource Department by responding to the day-to-... ...Comfortable communication with all levels of management and employees Must possess... ...Seniority level ~ Seniority level Entry level Employment type ~...
...Job Description Job Description The Assistant Project Manager Internship will be working with the project team and adjacent departments, providing a high level of coordination support in a variety of areas, partnering with construction project management and field...