Senior PV Leader, Global Post-Market Safety

MMS Holdings Inc; Phoenix (AZ); Remote; USD 120,000 - 160,000; Full time

Job summary

MMS Holdings Inc is seeking a seasoned pharmacovigilance leader to supervise global post-marketing case processing, ensuring quality, regulatory compliance, and client satisfaction. You will develop PV workflows, oversee safety data handling, and mentor team members across projects.

The role requires deep PV expertise, strong communication, and the ability to manage complex deliverables while aligning with GVP, FDA, and internal SOPs.

Qualifications

• Bachelor's degree in science or related field; advanced degrees preferred.
• Minimum 8 years’ experience in drug safety, pharmacovigilance, or related field.

Responsibilities

• Lead and oversee global post-marketing case processing activities from intake through reporting and case closure.
• Develop, maintain, and ownership of pharmacovigilance workflows, procedures, and work instructions as related to post marketing case processing.
• Establish quality review frameworks for case processing activities
• Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs.
• Proficient in ICH E2A, E2B(R3), and E2D guidelines
• Proficient in Pharmacovigilance quality systems
• Maintains an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial processes.
• Recognized as SME; provides strategic development internally and externally, directly negotiates with client.
• Process cases independently, understands steps involved with case processing. Leads creation/updates of high-quality deliverables.
• Extensive experience working within a safety database and directly interacts with clients.Expert knowledge of coding with MedDRA and WHO drug dictionary.
• Proficient in understanding impact of updates in related deliverables
• Independently managing/leading client meetings and CRMs for effective resolutions; provides mentorship to others.
• Proficient with managing a project from start to finish and compliant with process; provides mentorship to others; identifies efficiencies within department processes.
• Understand interactions between postmarket pharmacovigilance and US REMS requirements

Skills

Post-marketing pharmacovigilance

Client relationship management

Project leadership

Regulatory compliance

GVP FDA knowledge

Communication skills

Quality assurance

Education

Bachelor's degree in science

Master's degree or PhD preferred

Tools

PV databases

MedDRA coding

MS Office

Job description

MMS Holdings Inc is seeking a seasoned pharmacovigilance leader to supervise global post-marketing case processing, ensuring quality, regulatory compliance, and client satisfaction. You will develop PV workflows, oversee safety data handling, and mentor team members across projects.

The role requires deep PV expertise, strong communication, and the ability to manage complex deliverables while aligning with GVP, FDA, and internal SOPs.