Drug Safety and Pharmacovigilance Operations Manager

TL;DR

Drug Safety and Pharmacovigilance Operations Manager: Overseeing drug safety operations and vendor management activities to ensure compliance with global regulatory standards and internal procedures. Focus on monitoring vendor performance, managing cross-functional stakeholder relationships, and driving inspection readiness through robust quality control and process improvement strategies.

Location: Must be based in the U.S. (Fully remote role with occasional travel)

Salary: $133,000–$173,000 Annual

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Oversee eTMF management, PV vendor activities, and clinical study support to ensure alignment with regulatory standards.
• Create, track, and monitor KPIs and metrics for vendor performance monitoring.
• Serve as the primary liaison with internal cross-functional stakeholders including QA, Patient Safety, and Compliance.
• Address gaps in vendor case management processes and resolve inquiries related to ICSR processing.
• Enhance inspection readiness by developing problem-solving strategies, root cause analysis, and CAPA development.
• Facilitate onboarding, training, and mentorship for new team members within DSPV Operations.

Requirements

• Bachelor’s degree in life sciences, clinical research, or licensed healthcare professional status.
• Minimum 4-5 years of relevant industry experience, including at least 3 years in drug safety.
• In-depth knowledge of medical terminology, GCP, ICH guidelines, and global pharmacovigilance regulations.
• Proven ability to independently plan, organize, and manage multiple priorities.
• Proficiency in MS Office suite.
• Must be authorized to work in the U.S.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and flexible work schedules.
• Access to the Company Learning Institute, including LinkedIn Learning and mentorship programs.
• Employee resource groups and service recognition programs.