PV Safety Specialist

Anova Enterprises, Inc.; Schaumburg (IL); Sur place; USD 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

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Résumé du poste

Anova Enterprises, Inc. is seeking a PV Safety Specialist to manage safety reporting across clinical trials and related programs. The role emphasizes accurate ICSR handling, case-level assessments, and collaboration with sponsors and sites to maintain compliance.

The position focuses on timely, high-quality pharmacovigilance activities, including preparation of medical narratives and regulatory submissions in line with SOPs and regulatory requirements.

Qualifications

• Experience in pharmacovigilance and handling Individual Case Safety Reports (ICSRs).
• Ability to assess seriousness, expectedness, reportability, and completeness of safety information.
• Experience ensuring expedited safety reporting to regulators within required timelines.

Responsabilités

• Manage receipt, processing, tracking, and documentation of IC/SRs.
• Perform formal case-level assessments of adverse events.
• Prepare accurate medical narratives and follow-up queries as needed.
• Ensure timely regulatory submissions for expedited reports.

Description du poste

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…