Global Post-Market PV Lead — Senior Manager

MMS Holdings Inc; Miami (FL); À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

MMS Holdings Inc. is seeking an experienced pharmacovigilance leader to oversee global post-marketing case processing from intake to closure. You will own PV workflows, ensure GVP/FDA compliance, and mentor a growing team.

Exceptional leadership and deep PV knowledge are required for this role in a dynamic, worldwide CRO environment. Ideal candidates bring 8+ years in drug safety, familiarity with ISO standards, and strong communication skills to interact with clients and internal teams.

Qualifications

• Minimum of 8 years’ experience in drug safety or pharmacovigilance.
• Experience with drug safety databases.
• Proven leadership in the field.
• Strong MS Office proficiency.
• Experience with clinical trials/pharmaceutical development preferred.
• Excellent communication and problem-solving skills.
• Familiarity with ISO 9001/27001.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.

Responsabilités

• Lead global post-marketing case processing from intake through closure.
• Develop and own pharmacovigilance workflows and SOPs.
• Establish quality review frameworks for case processing.
• Ensure compliance with GVP, FDA, and company SOPs.
• Mentor team and lead client meetings.
• Interact with safety databases and perform MedDRA/WHO coding.
• Understand interactions between postmarket PV and REMS.

Connaissances

MS Office

Communication skills

Problem solving

Organizational skills

Pharmacovigilance knowledge

Formation

Bachelor's or equivalent in science

Masters/PharmD/PhD preferred

Outils

Drug safety databases

MedDRA coding

WHO drug dictionary

Description du poste

MMS Holdings Inc. is seeking an experienced pharmacovigilance leader to oversee global post-marketing case processing from intake to closure. You will own PV workflows, ensure GVP/FDA compliance, and mentor a growing team.

Exceptional leadership and deep PV knowledge are required for this role in a dynamic, worldwide CRO environment. Ideal candidates bring 8+ years in drug safety, familiarity with ISO standards, and strong communication skills to interact with clients and internal teams.