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 ICSRs arising from clinical trials, expanded access programs, spontaneous reports, literature sources, and other relevant safety reporting channels.
• Perform initial case assessments to determine validity, seriousness, expectedness, causality and potential regulatory reportability in accordance with applicable safety reporting requirements.
• Review adverse event information for completeness, clinical consistency, and accuracy, ensuring that all relevant information is appropriately captured within the safety database.
• Prepare accurate, comprehensive, and medically coherent case narratives that clearly describe the adverse event, relevant medical history, treatment exposure, clinical course, investigations, interventions, and outcomes.
• Identify missing, inconsistent, or ambiguous clinical information and generate appropriate follow-up queries to investigators, research sites, sponsors, or other reporting sources.
• Process initial and follow-up safety reports within established timelines, ensuring appropriate documentation and traceability of all case-related activities.
• Perform case data entry, MedDRA coding, and quality control reviews, as applicable, to support regulatory-compliant safety reporting.
• Maintain accurate and complete records of case processing activities, ensuring appropriate audit trails and inspection readiness.

Regulatory Safety Reporting and Compliance

• Manage the receipt, processing, tracking, and documentation of ICSRs arising from clinical trials, expanded access programs, spontaneous reports, literature sources, and other relevant safety reporting channels.
• Perform initial case assessments to determine validity, seriousness, expectedness, causality and potential regulatory reportability in accordance with applicable safety reporting requirements.
• Review adverse event information for completeness, clinical consistency, and accuracy, ensuring that all relevant information is appropriately captured within the safety database.
• Prepare accurate, comprehensive, and medically coherent case narratives that clearly describe the adverse event, relevant medical history, treatment exposure, clinical course, investigations, interventions, and outcomes.
• Identify missing, inconsistent, or ambiguous clinical information and generate appropriate follow-up queries to investigators, research sites, sponsors, or other reporting sources.
• Process initial and follow-up safety reports within established timelines, ensuring appropriate documentation and traceability of all case-related activities.
• Perform case data entry, MedDRA coding, and quality control reviews, as applicable, to support regulatory-compliant safety reporting.
• Maintain accurate and complete records of case processing activities, ensuring appropriate audit trails and inspection readiness.

Medical Review and Safety Data Quality

• Manage the receipt, processing, tracking, and documentation of ICSRs arising from clinical trials, expanded access programs, spontaneous reports, literature sources, and other relevant safety reporting channels.
• Perform initial case assessments to determine validity, seriousness, expectedness, causality and potential regulatory reportability in accordance with applicable safety reporting requirements.
• Review adverse event information for completeness, clinical consistency, and accuracy, ensuring that all relevant information is appropriately captured within the safety database.
• Prepare accurate, comprehensive, and medically coherent case narratives that clearly describe the adverse event, relevant medical history, treatment exposure, clinical course, investigations, interventions, and outcomes.
• Identify missing, inconsistent, or ambiguous clinical information and generate appropriate follow-up queries to investigators, research sites, sponsors, or other reporting sources.
• Process initial and follow-up safety reports within established timelines, ensuring appropriate documentation and traceability of all case-related activities.
• Perform case data entry, MedDRA coding, and quality control reviews, as applicable, to support regulatory-compliant safety reporting.
• Maintain accurate and complete records of case processing activities, ensuring appropriate audit trails and inspection readiness.
• Secure the input of study medical monitors(s), as needed to correctly document the validity, seriousness, expectedness, causality

Sponsor and Research Site Support

• Manage the receipt, processing, tracking, and documentation of ICSRs arising from clinical trials, expanded access programs, spontaneous reports, literature sources, and other relevant safety reporting channels.
• Perform initial case assessments to determine validity, seriousness, expectedness, causality and potential regulatory reportability in accordance with applicable safety reporting requirements.
• Review adverse event information for completeness, clinical consistency, and accuracy, ensuring that all relevant information is appropriately captured within the safety database.
• Prepare accurate, comprehensive, and medically coherent case narratives that clearly describe the adverse event, relevant medical history, treatment exposure, clinical course, investigations, interventions, and outcomes.
• Identify missing, inconsistent, or ambiguous clinical information and generate appropriate follow-up queries to investigators, research sites, sponsors, or other reporting sources.
• Process initial and follow-up safety reports within established timelines, ensuring appropriate documentation and traceability of all case-related activities.
• Perform case data entry, MedDRA coding, and quality control reviews, as applicable, to support regulatory-compliant safety reporting.
• Maintain accurate and complete records of case processing activities, ensuring appropriate audit trails and inspection readiness.

Education

• Bachelor's degree Nursing or another relevant healthcare or scientific discipline.
• Additional training or qualifications in pharmacovigilance, drug safety, clinical research, or regulatory affairs are desirable.

Experience

• 2-5 years of relevant experience in pharmacovigilance, drug safety, clinical research, or a related regulated healthcare environment.
• Demonstrated experience in ICSR processing, medical narrative preparation, and safety case quality review.
• Knowledge of adverse event seriousness criteria, expectedness assessments, expedited reporting requirements, and applicable pharmacovigilance regulations.
• Experience working with clinical trial safety reporting requirements, including IND safety reporting and SUSAR processes, is preferred.
• Familiarity with MedDRA coding, safety databases, and electronic regulatory reporting systems.
• Experience working within a CRO, biopharmaceutical company, or clinical research organization is advantageous.
• Familiarity with global pharmacovigilance requirements and regulatory frameworks, including ICH E2A, E2B(R3), FDA safety reporting regulations, and applicable EU/UK requirements, is desirable.