Global Drug Safety & PV Operations Manager (Hybrid)

Asahi Kasei Therapeutics, Inc.; Cary (NC); Hybrid; USD 120.000 - 130.000; Vollzeit

Benefits dieser Stelle

Health and insurance benefits

Training and development opportunities

Performance-based bonus eligibility

Zusammenfassung

Veloxis Pharmaceuticals, Inc., based in Cary, NC, is seeking a senior pharmacovigilance professional to lead safety operations in a hybrid role. You will oversee ICSR processing, safety data exchanges, and regulatory submissions, partnering with cross-functional teams to ensure compliance.

In this role you will coordinate with external vendors, monitor KPIs, ensure inspection readiness, and contribute to safety governance across US, Europe and Japan, while traveling approximately 10% as needed.

Qualifikationen

• Bachelor's degree in life sciences, nursing, pharmacy, or related health profession.
• At least 5 years of pharma drug safety and pharmacovigilance experience.
• Experience with Argus and vendor management in pharmacovigilance.
• Knowledge of global PV practices and regulatory reporting.

Aufgaben

• Serve as resource for pharmacovigilance activities across functions.
• Oversee vendor performance and safety outputs within budget.
• Monitor US AE call center and AE processing by vendors.
• Review ICSR narratives and coding per MedDRA; ensure source accuracy.
• Support audits, inspections, and regulatory submissions.

Kenntnisse

Pharmacovigilance

Vendor management

ICSR processing

Regulatory compliance

Argus experience

Ausbildung

Bachelor's degree in life sciences, nursing, pharmacy, or related healthcare profession

Tools

Argus

Jobbeschreibung

Veloxis Pharmaceuticals, Inc., based in Cary, NC, is seeking a senior pharmacovigilance professional to lead safety operations in a hybrid role. You will oversee ICSR processing, safety data exchanges, and regulatory submissions, partnering with cross-functional teams to ensure compliance.

In this role you will coordinate with external vendors, monitor KPIs, ensure inspection readiness, and contribute to safety governance across US, Europe and Japan, while traveling approximately 10% as needed.