Global Post-Market Pharmacovigilance Leader

MMS Holdings Inc; Chicago (IL); Remote; USD 140,000 - 180,000; Full time

Job summary

MMS Holdings Inc is seeking a seasoned Pharmacovigilance professional to lead global post-marketing case processing from intake through reporting and closure. This role focuses on developing PV workflows, ensuring GVP and FDA compliance, and mentoring team members.

The candidate should have extensive experience with MedDRA and WHO drug dictionaries, and be capable of directing client-facing meetings while maintaining high-quality deliverables in a fast-paced CRO environment.

Qualifications

• 8+ years of experience in drug safety/pharmacovigilance or related field.
• Experience with regulatory guidelines and quality systems.

Responsibilities

• Lead global post-marketing case processing from intake to closure.
• Develop and own pharmacovigilance workflows and SOPs.
• Ensure compliance with GVP, FDA requirements, and company SOPs.
• Mentor team members and lead client meetings.
• Interact with safety databases and provide regulatory-submission support.

Skills

Post-marketing case processing

Pharmacovigilance

GVP/FDA compliance

ICH guidelines (E2A/E2B/E2D)

Safety database usage

Client meetings/leadership

Education

Master’s degree in science/medical field

PharmD or PhD preferred

Tools

MedDRA

WHO drug dictionary

Job description

MMS Holdings Inc is seeking a seasoned Pharmacovigilance professional to lead global post-marketing case processing from intake through reporting and closure. This role focuses on developing PV workflows, ensuring GVP and FDA compliance, and mentoring team members.

The candidate should have extensive experience with MedDRA and WHO drug dictionaries, and be capable of directing client-facing meetings while maintaining high-quality deliverables in a fast-paced CRO environment.