Global PV Lead, Post-Market Safety & Compliance

MMS; Canton Charter Township (MI); Vor Ort; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

MMS, a data-focused clinical research organization, seeks an experienced pharmacovigilance leader to drive global post-marketing case processing and ensure regulatory compliance. The role emphasizes delivering accurate safety narratives and maintaining PV systems across a four-continent footprint.

You will mentor teams, interact with clients, and ensure high-quality deliverables using MedDRA and safety databases while upholding trial process standards and ISO guidelines.

Qualifikationen

• Minimum of 5 years’ experience in drug safety, pharmacovigilance, or similar field.
• Experience with GVP, FDA requirements, and regulatory standards.
• Proficiency with drug safety databases and MS Office applications.
• Strong communication, problem-solving, and organizational skills.
• Hands-on experience with clinical trials and pharmaceutical development preferred.
• Familiarity with ISO 9001 and ISO 27001 standards and 21 CFR Part 11/GCP.

Aufgaben

• Lead and oversee global post-marketing case processing activities from intake through reporting and case closure.
• Develop and maintain pharmacovigilance workflows, procedures, and work instructions.
• Ensure compliance with GVP, FDA requirements, and company SOPs.
• Maintain expertise in ICH E2A, E2B(R3), and E2D guidelines; apply in daily work.
• Manage safety databases and direct client interactions; mentor junior staff.
• Lead client meetings, negotiate deliverables, and drive high-quality narratives.
• Oversee end-to-end case processing and ensure accurate coding with MedDRA/WHO dictionaries.
• Identify process efficiencies and ensure alignment with regulatory changes.

Jobbeschreibung

MMS, a data-focused clinical research organization, seeks an experienced pharmacovigilance leader to drive global post-marketing case processing and ensure regulatory compliance. The role emphasizes delivering accurate safety narratives and maintaining PV systems across a four-continent footprint.

You will mentor teams, interact with clients, and ensure high-quality deliverables using MedDRA and safety databases while upholding trial process standards and ISO guidelines.