PV Safety Specialist

The Pharmacovigilance (PV) team exists to ensure the detection, assessment, understanding, and prevention of adverse effects or other treatment related problems in clinical trials managed by Anova.

The PV Safety Specialist is responsible for the accurate, timely, and compliant management of Individual Case Safety Reports (ICSRs) throughout the safety case lifecycle. The role includes the receipt, review, assessment, processing, documentation, quality control, and regulatory submission of safety reports arising from clinical trials, expanded access programs, and other applicable sources.

The PV Safety Specialist performs formal case-level assessments of adverse events submitted by site investigators, including the evaluation of seriousness, expectedness, reportability, and completeness of safety information. The role is responsible for preparing accurate, comprehensive medical narratives, identifying missing or unclear information, generating appropriate follow-up queries, and ensuring that cases meeting expedited reporting requirements are submitted to regulatory authorities within applicable timelines.

Working closely with sponsors, clinical research sites, investigators, medical monitors, and internal clinical operations teams, the PV Safety Specialist ensures that all pharmacovigilance activities are conducted in accordance with applicable regulatory requirements, sponsor-specific procedures, internal Working Practices, Standard Operating Procedures (SOPs), and established quality standards.

The PV Safety Specialist demonstrates an unwavering commitment to quality, regulatory compliance, operational excellence, and customer service, continually identifying opportunities to improve pharmacovigilance processes and enhance the experience of internal and external stakeholders.

Key Responsibilities

Individual Case Safety Report Management

• Manage the receipt, processing, tracking, and documentation of IC…