Sr. Manager, Global Labeling & PV Operations

Taiho Oncology, Inc. • Princeton, NJ

8d • Hybrid

About The Position

The Senior Manager, Global Labeling Innovation & PV Operations, leads the creation, maintenance, and continuous improvement of auto-labeling data sheets for use in the global safety database. This role is responsible for ensuring labeling documents (including USPI, CCDS, IB, SmPC, and others) are current, accurate, and compliant with global regulatory requirements for ICSR assessments. The position also supports PV Operations through regulatory intelligence review and the configuration and testing of safety database reporting rules. The ideal candidate brings deep expertise in PV case processing and operational excellence.

Requirements

• Bachelor’s degree in healthcare related field required.
• Minimum of 10 years’ progressive experience in pharmacovigilance in a pharmaceutical, biotech or related environment.
• Minimum 7 years’ experience in pharmacovigilance, drug safety, or regulatory labeling within the pharmaceutical or biotechnology industry.
• Strong experience with minimum of 5 years of PV case processing and operations.
• Past experience managing and developing direct reports.
• In-depth knowledge of MedDRA, global labeling requirements (FDA, EMA, ICH), and safety database management.
• Experience with configuration and validation of safety database reporting rules (e.g., LSMV, Argus).
• In-depth knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
• Knowledge of adverse event regulatory reporting requirements of both clinical trial and post marketing reports.
• Excellent analytical, organizational, and communication skills.

Nice To Haves

• RN, R.Ph., or Pharm D. degree is highly preferred.

Responsibilities

• Develop, update, and maintain auto-labeling data sheets for the safety database, ensuring alignment with regulatory requirements and internal procedures.
• Collaborate with PV Scientists and PV Medical Surveillance Physicians to manage and update auto-labeling data sheets with annual IB update.
• Ensure labeling documents such as USPI, CCDS, Investigator’s Brochure (IB), SmPC, and other global product labels are current for the assessment of ICSRs.
• Coordinate with relevant stakeholders to incorporate MedDRA updates into labeling data sheets.
• Serve as the subject matter expert for labeling processes, providing guidance and training to cross-functional teams.
• Review and evaluate regulatory intelligence updates impacting PV operations globally, ensuring timely impact assessment.
• Collaborate with relevant stakeholders to operationalize new or revised regulations and guidance.
• Oversight of vendor reconciliation process and other outsourced PV activities.
• Oversee PV vendor governance.
• Coordinate with PV safety database administrators to configure, test, and validate reporting rules in the safety database, ensuring compliance with global and local reporting requirements.
• Investigate and resolve issues related to reporting rules and case distribution.
• Contributes to inspection readiness and supports Health Authority inspections of Taiho’s pharmacovigilance function.
• Participates in internal PV meetings (Process improvement meetings, safety database team meetings, etc.) based on specific topics.
• This role may supervise PV team members.

Benefits

• full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees