Drug Safety Specialist

Overview

• Serve as a Drug Safety Specialist in a hybrid work environment, contributing to pharmacovigilance activities for investigational and marketed products.
• Process adverse event reports, ensuring compliance with regulatory requirements and guidelines, including FDA and ICH standards.
• Collaborate with clinical, regulatory, and contract research organizations to ensure safety pharmacovigilance activities are performed effectively.
• Utilize clinical judgment to code adverse events, medical history, and medications accurately.
• Contribute to ongoing safety surveillance, identifying events of special interest and performing aggregate data reviews.
• Act as a liaison between external reporting sources and internal departments, ensuring seamless communication and coordination.
• Participate in clinical project teams, reviewing and providing input on study-related documents.
• Assist in responding to regulatory queries and compiling safety information for submissions.

Key Responsibilities & Duties

• Process adverse event reports, ensuring compliance with regulatory requirements and guidelines.
• Track cases from receipt to closure, collaborating with clinical and regulatory teams.
• Perform verification of safety data, coding adverse events and synthesizing clinical information into reports.
• Coordinate vendor management activities, acting as a safety representative between external and internal teams.
• Contribute to the development of standard operating procedures for pharmacovigilance activities.
• Participate in clinical project teams, reviewing and commenting on study-related documents.
• Assist in responding to health authority queries and compiling safety information for regulatory submissions.
• Perform quality improvement initiatives to ensure data consistency and high-quality standards.

Job Requirements

• Doctor of Pharmacy (PharmD) degree required.
• Minimum of 3 years of drug safety or clinical safety experience, with 5 years preferred.
• Knowledge of domestic and international regulatory safety reporting requirements, including FDA and ICH guidelines.
• Experience with safety application databases such as Clintrace, ArisG, or Argus.
• Ability to make clinical decisions and formulate queries based on medical knowledge.
• Proactive problem-solving skills and ability to work independently.
• Excellent interpersonal, communication, and organizational skills.
• Experience processing oncology cases is preferred.