Manager, Global Drug Safety & Pharmacovigilance

Veloxis Pharmaceuticals, an Asahi Kasei Group company based in Cary, NC, focuses on transforming transplant medicine as the primary partner to transplant healthcare providers and their patients. We offer a dynamic, innovative workplace that encourages professional development and embraces diversity, seeking creative, intelligent, and passionate individuals who thrive in a collaborative team environment.

About the role

This position provides management-level oversight, planning, and execution of post-marketing and clinical trial safety activities, ensuring compliance, quality, inspection readiness, and operational excellence. The role serves as a safety liaison with cross-functional teams, license partners, and contract safety organizations responsible for global drug safety and pharmacovigilance.

The base compensation range for this role is $120–130K, influenced by factors such as time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business/economic conditions.

Responsibilities

• Serve as a resource and contact for pharmacovigilance operational activities within the company.
• Oversee vendor performance and service outputs, including:
  • US adverse event (AE) call center operations.
  • Adverse event processing by outsourced vendors, including compliance monitoring through reports/KPIs.
  • Quality audits of individual case safety reports (ICSR), focusing on narrative accuracy, MedDRA coding, expectedness against RSIs, and query appropriateness.
  • Adverse event reconciliation between safety and clinical databases, and exchanges with licensing partners.
  • Review of safety-related sections of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP).
  • Review and approval of pharmacovigilance documents submitted to the Trial Master File (TMF).
  • Vendor project-specific training.
  • Collaboration with vendors to develop Safety Management Plans (SMP), forms, templates, and process-related documents for improvement and standardization.
  • Maintain knowledge of safety systems (Argus experience preferred).
• Create and maintain standard operating procedures and working practices to ensure inspection readiness and compliance.
• Support internal/external audits and regulatory inspections.
• Manage pharmacovigilance vendor contracts and forecasting activities.
• Assist in managing license partner safety data exchange agreements (SDEA).
• Coordinate product safety operations functions in accordance with regulations and company policies.
• Prepare and review regulatory submissions, such as safety reports and aggregate/periodic reports.
• Represent the company in product safety meetings with cross-functional teams, license partners, and contract safety organizations.
• Provide training to company personnel and third parties on pharmacovigilance requirements and compliance.
• Maintain current knowledge of pharmacovigilance regulations and guidelines, particularly in the US, Europe, and Japan.

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related healthcare profession with relevant experience.
• At least 5 years of pharmaceutical industry experience in drug safety and pharmacovigilance, including development and post-marketed products.
• Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, KPIs/metrics, and contract management.
• Strong knowledge of ICSR processing and the adverse event lifecycle.
• Experience with drug safety databases, especially Argus; data migration experience preferred.
• Ability to independently identify, analyze, and solve complex operational and data-related issues.
• Strong understanding of current pharmacovigilance practices and global regulations, including regulatory reporting requirements.

Skills

• Self-motivated, detail-oriented, with strong prioritization and planning abilities.
• Excellent written and verbal communication skills.
• Ability to work both independently and within a matrixed team in a dynamic, fast-paced environment with shifting priorities.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro.

Schedule

Hybrid role with approximately 10% travel.

Benefits

• Competitive compensation package, including performance-based bonus eligibility.
• Health and insurance benefits.
• Training and development opportunities.