Pharmacovigilance QA Auditor Specialist

Scorpion Therapeutics; New Jersey; Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work setup

Travel opportunities (25% travel)

Job summary

Johnson & Johnson is seeking a Pharmacovigilance QA Auditor Specialist to ensure quality and compliance across PV activities. Hybrid role based in New Jersey with travel up to 25%.

You will lead routine PV internal and external audits, support audits of data, facilities, and processes in GxP/non-regulated areas, and assist with regulatory inspections. Collaboration with business partners and the development of training materials may be required.

Qualifications

• Minimum 4 years of Pharmacovigilance experience.
• Strong project management, data analysis, and communication skills.
• Proficiency with Microsoft Office.

Responsibilities

• Lead routine PV internal and external audits.
• Support audits of data, facilities, and processes in GxP/non-regulated areas.
• Assist with regulatory inspections.
• Collaborate with business partners and provide compliance guidance.
• Develop training materials when appropriate.

Skills

Pharmacovigilance

Quality assurance

Data analysis

Project management

Communication

Tools

Microsoft Office

Job description

Role

Pharmacovigilance QA Auditor Specialist to ensure quality and compliance across Johnson & Johnson's pharmacovigilance activities.

Responsibilities

leading routine PV internal and external audits, supporting audits of data, facilities, and processes in GxP/non-regulated areas, and assisting with regulatory inspections. The role involves collaboration with business partners, providing compliance guidance, and potentially developing training materials.

Requirements

minimum 4 years in Pharmacovigilance, strong project management, data analysis, and communication skills; proficient with Microsoft Office.

Preferred

broad auditing experience, familiarity with various audit types, and understanding of auditing landscapes.

HighValue

pharmacovigilance, PV audits, GxP compliance, regulatory inspections, 25% travel.

Location

Raritan, NJ; Titusville, NJ; Horsham, PA; hybrid work setup.