Responsibilities

The Associate Drug Safety Specialist will perform day-to-day Pharmacovigilance (PVG) activities within a highly regulated environment, including collection, monitoring, assessment, evaluation, research, and tracking of safety information. Responsibilities include adverse event data entry, coding and assessment, case review, follow-up, tracking of reports, and regulatory reporting activities. The role involves collaborating with various parties, such as project team members, client contacts, investigators, and adverse event/reporters, and third-party vendors. The Specialist will review regulatory/pharmacovigilance publications, maintain medical understanding of therapeutic areas and disease states, review cases for quality and accuracy, prepare and maintain regulatory safety reports, and may participate in on-call duties for specific projects to ensure 24-hour coverage for case intake.