Senior Drug Safety Specialist

Senior Drug Safety Specialist Overview

• The Senior Drug Safety Specialist will oversee pharmacovigilance activities for investigational and marketed products, ensuring compliance with regulatory guidelines and industry standards.
• Collaborate with cross-functional teams to track and resolve adverse event cases efficiently, maintaining high data quality and consistency.
• Utilize clinical judgment to synthesize complex safety data into accurate reports, contributing to ongoing safety surveillance initiatives.
• Coordinate with external vendors, call centers, and investigator sites to streamline safety reporting processes.
• Participate in clinical project teams, providing expert input on study-related documents and safety management plans.
• Contribute to the development of standard operating procedures and respond to regulatory queries effectively.
• Support regulatory submissions by compiling and supplying safety information for reports such as IND safety reports and PSURs.
• This hybrid role offers flexibility and the opportunity to work on impactful projects in drug safety.

Senior Drug Safety Specialist Key Responsibilities & Duties

• Process adverse event reports, ensuring compliance with FDA, ICH guidelines, and partnership agreements.
• Perform SAE reconciliation, ensuring timely case closure and data accuracy.
• Coordinate with clinical operations, regulatory affairs, and external vendors for seamless pharmacovigilance activities.
• Contribute to safety surveillance efforts, identifying events of special interest and reviewing aggregate data.
• Develop and write safety management plans and standard operating procedures for assigned studies.
• Respond to health authority queries and compile safety information for regulatory submissions.
• Participate in clinical project teams, reviewing study-related documents and providing safety expertise.
• Ensure continuous quality improvement in safety data and processes across projects.

Senior Drug Safety Specialist Job Requirements

• Bachelor of Science (BS) degree in a relevant field is required.
• Minimum of 3 years of drug safety or clinical safety experience; 5 years preferred.
• Clinical experience in a medical setting with general medical and pharmacology knowledge.
• Proficiency in safety application databases such as Clintrace, ArisG, or Argus.
• Knowledge of domestic and international regulatory safety reporting requirements.
• Experience processing oncology cases is preferred.
• Strong interpersonal, communication, and organizational skills with attention to detail.
• Ability to work independently and as part of a team, prioritizing workload effectively.