Pharmacovigilance Compliance & Training Manager

Scorpion Therapeutics; Redwood City (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Pharmacovigilance/Quality Compliance professional to support the global PV QMS and regulatory alignment in a fast-paced biotech environment.

You will author and maintain PV procedures, develop role-based training, and help drive metrics and improvements across the PV system. This role requires collaboration across functions and vendors to ensure compliance with FDA, EMA, ICH guidelines.

Qualifications

• 5+ years patient safety/PV experience
• Experience with PV compliance, standards, training or quality systems
• Experience managing quality events (deviations, CAPAs, change controls)
• Inspection/audit support experience and project management
• Authorized to work in the United States on a full-time basis

Responsibilities

• Support operation and maintenance of the PV QMS per regulatory requirements.
• Author, review, revise, and maintain PV procedures and controlled documents.
• Develop and maintain PV training programs, including tracking completion.
• Develop, compile and report PV compliance metrics and KPIs.
• Support inspection readiness and regulatory inspections.
• Manage deviations, CAPAs and change controls with investigation support and documentation.
• Monitor PV regulatory changes and update procedures and training.
• Maintain PSMF updates and coordinate reviews across functions and vendors.

Skills

PV regulations knowledge

QMS experience

Documentation & records

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree in life sciences/healthcare

Advanced degree preferred (RN/PharmD)

Tools

Veeva or similar QMS

Job description

Scorpion Therapeutics is seeking a Pharmacovigilance/Quality Compliance professional to support the global PV QMS and regulatory alignment in a fast-paced biotech environment.

You will author and maintain PV procedures, develop role-based training, and help drive metrics and improvements across the PV system. This role requires collaboration across functions and vendors to ensure compliance with FDA, EMA, ICH guidelines.