Global Drug Safety & PV Leader

Asahi Kasei Bioprocess America, Inc.; Cary (NC); Híbrido; USD 120.000 - 130.000; Jornada completa

Descripción de la vacante

Veloxis Pharmaceuticals, Inc., based in Cary, NC, is seeking a Manager, Global Drug Safety & Pharmacovigilance to lead post-marketing safety activities and ensure regulatory compliance. The role collaborates with cross-functional teams and external partners to maintain inspection readiness and high-quality safety data.

The ideal candidate has 5+ years in pharmacovigilance, strong vendor management, and experience with ICSR processing and Argus.

Formación

• Bachelor's degree in life sciences or related field.
• 5+ years in pharma drug safety/pharmacovigilance.
• Vendor management experience with CROs.
• Strong ICSR processing and adverse event lifecycle knowledge.
• Experience with Argus or similar safety databases.

Responsabilidades

• Provide management level oversight, planning and execution of post-marketing and clinical trial safety activities.
• Ensure compliance, quality, inspection readiness and operational excellence across safety processes.
• Oversee vendor performance, PKIs/metrics, and safety data exchange with partner organizations.
• Support regulatory submissions and safety reports with cross-functional teams.

Conocimientos

Vendor management

ICSR processing

Pharmacovigilance oversight

Safety data exchange agreements

Regulatory compliance

Project management

KPIs / metrics

Communication skills

Educación

Bachelor's degree in life sciences

Herramientas

Argus

Descripción del empleo

Veloxis Pharmaceuticals, Inc., based in Cary, NC, is seeking a Manager, Global Drug Safety & Pharmacovigilance to lead post-marketing safety activities and ensure regulatory compliance. The role collaborates with cross-functional teams and external partners to maintain inspection readiness and high-quality safety data.

The ideal candidate has 5+ years in pharmacovigilance, strong vendor management, and experience with ICSR processing and Argus.