Senior Global Pharmacovigilance Lead - Post-Market Safety

MMS Holdings Inc; United States; Hybrid; USD 120,000 - 180,000; Full time

Job summary

MMS Holdings Inc, a data-focused clinical research organization, seeks an experienced pharmacovigilance professional to lead global post-marketing case processing and drive regulatory compliance.

The role requires extensive PV knowledge, strong client-facing experience, and the ability to mentor teams. You will navigate FDA regulations, GVP, and ISO standards while collaborating with multinational clients on safety deliverables.

Qualifications

• 8+ years of experience in drug safety or pharmacovigilance.
• Expert knowledge of scientific principles and concepts.
• Familiarity with ISO 9001 / ISO 27001 preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Responsibilities

• Lead global post-marketing case processing from intake to closure.
• Develop and own PV workflows and work instructions.
• Establish quality review frameworks for case processing.
• Ensure compliance with GVP, FDA requirements and SOPs.
• Mentor others and lead client meetings and CRMs.
• Manage projects end-to-end and drive process improvements.
• Understand REMS requirements and drug safety regulations.

Skills

Pharmacovigilance experience

Client management

GVP FDA guidelines knowledge

Project management

MedDRA coding

Education

Bachelor's in science/medical field

Advanced degree preferred (PharmD/PhD)

Tools

Drug safety databases

MS Office

Job description

MMS Holdings Inc, a data-focused clinical research organization, seeks an experienced pharmacovigilance professional to lead global post-marketing case processing and drive regulatory compliance.

The role requires extensive PV knowledge, strong client-facing experience, and the ability to mentor teams. You will navigate FDA regulations, GVP, and ISO standards while collaborating with multinational clients on safety deliverables.