California Licensed Pharmacovigilance Manager

Job Summary

California Licensed Pharmacovigilance Manager, oversees global pharmacovigilance operations for clinical trials and post-marketing programs in a full-time capacity, ensuring compliance and operational readiness for product launches and country expansions.

Key Responsibilities

• Lead execution of global pharmacovigilance operational activities across clinical trial and post-marketing programs
• Manage safety reporting activities and ensure compliance with global regulations
• Provide oversight and direction to vendors and cross-functional partners to ensure quality and consistency in case processing

Required Qualifications, Training, and Education

• Bachelor's degree in life sciences, pharmacy, nursing, or related scientific discipline required
• Advanced degree or healthcare professional qualification (e.g., Pharm.D., RN/BSN/MSN) preferred
• Pharmacovigilance experience, including clinical trial and post-marketing PV
• Experience with global safety database configuration and maintenance (Argus)
• Strong knowledge of global pharmacovigilance regulations and ICSR reporting requirements