Senior Post-Market Pharmacovigilance Lead

MMS; Miami (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Great culture and recognition

Career development opportunities

Job summary

MMS Holdings is seeking an experienced pharmacovigilance professional to lead global post-marketing case processing from intake to closure. You will develop workflows, ensure regulatory compliance, and interact with clients for strategic narrative development.

The role requires 5+ years in drug safety, expertise in MedDRA/WHO dictionaries, and strong communication skills. A proactive mentor, you will guide team members and drive process improvements within a dynamic PV function.

Qualifications

• Minimum 5 years’ experience in drug safety, pharmacovigilance, or similar field.
• Expert knowledge of scientific principles and concepts.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trials and pharmaceutical development.
• Familiarity with ISO 9001 and ISO 27001 standards.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
• Excellent communication and problem-solving skills.

Responsibilities

• Lead and oversee global post-marketing case processing activities from intake through reporting and case closure.
• Develop and maintain pharmacovigilance workflows, procedures, and instructions.
• Ensure compliance with GVP, FDA requirements, and SOPs.
• Lead client meetings and provide strategic narrative development.
• Mentor colleagues and improve department processes.
• Manage projects from start to finish with quality deliverables.

Skills

Pharmacovigilance knowledge

Scientific principles

Communication skills

Problem-solving

Organizational skills

Project leadership

Client meetings

Leadership

MS Office

Clinical trial experience

Quality systems

Education

Bachelor's degree in scientific/medical field

Master's degree (preferred)

PharmD (preferred)

PhD (preferred)

Tools

MedDRA

WHO Drug Dictionary

Drug safety databases

Job description

MMS Holdings is seeking an experienced pharmacovigilance professional to lead global post-marketing case processing from intake to closure. You will develop workflows, ensure regulatory compliance, and interact with clients for strategic narrative development.

The role requires 5+ years in drug safety, expertise in MedDRA/WHO dictionaries, and strong communication skills. A proactive mentor, you will guide team members and drive process improvements within a dynamic PV function.