Manager, Global Drug Safety & Pharmacovigilance

Overview

The Asahi Kasei Group operates with a commitment to creating for tomorrow. Veloxis Pharmaceuticals, an Asahi-Kasei Group Company based in Cary, NC, focuses on transforming transplant medicine and partnering with the transplant healthcare community. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment to join our team and contribute to patient-centric programs.

Our success is tied to the contribution of every team member, with a valuable and competitive compensation package that includes health and insurance benefits, training and development opportunities, and performance-based bonus eligibility.

Job Description

This position is primarily responsible for providing management-level oversight, planning and execution of post-marketing and clinical trial safety activities to ensure compliance, quality, inspection readiness, and operational excellence. The incumbent also 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 and is influenced by factors such as experience, skills, performance, and business conditions.

Responsibilities

• Serve as a resource and contact for other functions within the company for pharmacovigilance operational activities.
• Oversee vendor performance and outputs, including: US adverse event (AE) call center management and adverse event processing by outsourced vendors.
• Monitor compliance through various monitoring reports and KPIs and participate in quality audits of individual case safety reports (ICSR), with focus on accuracy of narrative, MedDRA coding, expectedness against RSIs, and appropriate follow-up queries to sites/reporters.
• Oversee adverse event reconciliation between safety and clinical databases, and adverse events exchanged with licensing partners.
• Review safety-related sections of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP) and approve pharmacovigilance documents for the Trial Master File (TMF).
• Provide vendor-specific training and collaborate with vendors to develop Safety Management Plans (SMP) and related forms and templates.
• Collaborate with vendors to develop process-related documents for improvement and standardization of new processes.
• Maintain knowledge of safety systems (Argus experience preferred) and assist in creating and maintaining standard operating procedures to ensure inspection readiness and regulatory compliance.
• Support internal and external audits and regulatory inspections; assist in management of pharmacovigilance vendor contracts and forecasting activities.
• Assist in management of license partner safety data exchange agreements (SDEA); establish and coordinate all product safety operations functions in accordance with regulations and policies.
• Assist in preparation and review of regulatory submissions, such as safety reports and aggregate/periodic reports; represent the company in product safety meetings with cross-functional teams and partners.
• Provide training to company personnel and third parties for pharmacovigilance requirements and regulatory compliance.
• Maintain current knowledge of regulations and regulatory guidelines, particularly in the US, Europe, and Japan.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related healthcare profession with relevant experience.
• At least 5 years of pharmaceutical industry drug safety and pharmacovigilance experience involving development and post-marketed products.
• Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, KPI/metrics establishment, 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.
• Self-motivated, detail-oriented, with the ability to prioritize and plan effectively.
• Excellent written and verbal communication skills; ability to work independently and within a matrixed team in a dynamic environment.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro.

Travel

Approximately 10% travel required.

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide the company with the ability to continuously support the changes in the economy, society, and environment.