Global PV Senior Manager - Post-Market Safety & Compliance

MMS; Aurora (CO); Remote; USD 120,000 - 160,000; Full time

Job summary

MMS, a data-focused clinical research organization, seeks an experienced pharmacovigilance professional to lead global post-marketing case processing and ensure adherence to GVP, FDA requirements, and ISO standards. You will mentor teams, manage client interactions, and drive quality deliverables across safety databases.

Ideal candidates have 8+ years in drug safety, strong knowledge of MedDRA, WHO dictionaries, and excellent communication skills, with a track record of regulatory compliance.

Qualifications

• 8+ years in drug safety or pharmacovigilance.
• Expert knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, GCP.
• Experience with pharmacovigilance databases and MedDRA/WHO dictionaries.
• Strong communication, leadership, and client engagement skills.

Responsibilities

• Lead global post-marketing case processing from intake to closure.
• Develop and maintain pharmacovigilance workflows and SOPs.
• Establish quality review frameworks for case processing.
• Ensure compliance with GVP and FDA requirements.
• Provide SME guidance and mentor teammates.
• Lead client meetings and manage CRM for issue resolution.
• Manage projects end-to-end with process improvements.
• Understand REMS requirements and regulatory updates.

Skills

Pharmacovigilance

Drug safety

GVP knowledge

MedDRA

Client management

Project leadership

Regulatory knowledge

MS Office

Education

Advanced degree (PharmD/PhD)

Science degree

Tools

MedDRA

WHO dictionary

Safety databases

Job description

MMS, a data-focused clinical research organization, seeks an experienced pharmacovigilance professional to lead global post-marketing case processing and ensure adherence to GVP, FDA requirements, and ISO standards. You will mentor teams, manage client interactions, and drive quality deliverables across safety databases.

Ideal candidates have 8+ years in drug safety, strong knowledge of MedDRA, WHO dictionaries, and excellent communication skills, with a track record of regulatory compliance.