Global Post-Market PV Lead – Case Processing & Compliance

MMS Holdings Inc; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

MMS Holdings Inc is seeking a senior pharmacovigilance professional to lead global post-marketing case processing. You will own workflows, ensure regulatory compliance, and mentor team members. Primary focus includes interaction with clients and senior stakeholders across regions.

Ideal candidates bring 8+ years in drug safety or PV, expertise in GVP and FDA requirements, and strong communication skills to navigate complex regulatory challenges. MSc/PhD or PharmD is preferred.

Qualifications

• Minimum of 8 years of experience in drug safety or pharmacovigilance.
• Experience with post-marketing case processing and global activities is required.
• Familiarity with ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP is preferred.

Responsibilities

• Lead and oversee global post-marketing case processing from intake through reporting and closure.
• Develop and own pharmacovigilance workflows, procedures, and work instructions for post-marketing case processing.
• Establish quality review frameworks for case processing and ensure GVP and FDA compliance.

Skills

Pharmacovigilance

Drug safety

Regulatory compliance

Communication

Education

Science degree (BS/BA)

Advanced degree preferred (MS/PhD/PharmD)

Tools

MS Office

Drug safety databases

Job description

MMS Holdings Inc is seeking a senior pharmacovigilance professional to lead global post-marketing case processing. You will own workflows, ensure regulatory compliance, and mentor team members. Primary focus includes interaction with clients and senior stakeholders across regions.

Ideal candidates bring 8+ years in drug safety or PV, expertise in GVP and FDA requirements, and strong communication skills to navigate complex regulatory challenges. MSc/PhD or PharmD is preferred.