Senior Manager, Pharmacovigilance

Role Summary

Senior Manager, Pharmacovigilance – support ongoing clinical trials, ensure patient safety and regulatory compliance throughout the drug development lifecycle, and collaborate with safety physicians, clinical teams, and external stakeholders on safety data and oversight.

Responsibilities

• Oversee pharmacovigilance activities for assigned clinical programs, ensuring alignment with global regulatory requirements and internal SOPs.
• Review, evaluate, and provide managerial oversight of adverse event (AE) reports, including serious adverse events (SAEs), ensuring accurate assessment and timely submission to regulatory authorities and ethics committees.
• Ensure quality and accuracy of safety data review within the safety database and direct reconciliation efforts with clinical databases to maintain data integrity.
• Contribute to the development of safety sections within clinical documents, including protocols, investigator brochures, and clinical study reports.
• Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings, including preparation of agendas, meeting materials, guided discussions, documentation of minutes, and follow-up on action items.
• Contribute strategically to the preparation of aggregate safety reports such as the DSUR.
• Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit‚Äìrisk evaluations.
• Serve as a subject matter expert to internal stakeholders and external partners on safety-related topics, providing guidance and ensuring consistent communication.
• Ensure organizational compliance with global pharmacovigilance regulations (FDA, EMA, ICH) and company policies.
• Manage and oversee pharmacovigilance-related quality events, including change controls, deviations, and CAPAs, ensuring timely resolution and documentation.
• Supervise and ensure accurate documentation of DSMB and SRC meetings and maintain records within designated systems and repositories.

Qualifications

• Education: PharmD or RN degree required.
• Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry.
• Proven experience reviewing adverse events and working closely with safety physicians.
• Hands-on experience supporting DSMBs and SRCs and preparing safety deliverables.
• Proficiency in Microsoft Office Suite and Microsoft Teams, with the ability to leverage these tools for efficient communication, scheduling, and documentation.
• Strong knowledge of global PV regulations (FDA, EMA, ICH guidelines).
• Excellent analytical, organizational, and communication skills.
• Ability to thrive in a fast-paced, start-up environment and manage multiple priorities.
• Fluency with Argus safety database.
• Familiarity with rare disease or oncology programs.
• Prior experience in a start-up or small biotech setting.

Skills

• Safety data management
• Regulatory compliance (FDA, EMA, ICH)
• AE/SAE assessment and reporting
• DSMB/SRC coordination
• Risk assessment and signal detection
• Documentation and data integrity
• Cross-functional collaboration

Education

• PharmD or RN degree required

Additional Requirements

• Remote work within the United States is supported.