Global Post-Market Pharmacovigilance Lead

MMS Holdings Inc; Austin (TX); Remoto; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

MMS Holdings Inc is seeking a senior pharmacovigilance leader to oversee global post‑marketing case processing from intake to closure. You will develop PV workflows and ensure GVP/FDA compliance while serving as SME for clients and mentoring teams.

Applicants should have deep knowledge of ICH guidelines, pharmacovigilance systems, and regulatory expectations, enabling strategic input across projects and client interactions.

Competenze

• College graduate in scientific or clinical discipline; advanced degrees preferred.
• 8+ years in drug safety, pharmacovigilance, or related field.
• Expert knowledge of scientific principles and regulatory concepts.
• Experience with drug safety databases and clinical trial processes.
• Strong communication and problem‑solving abilities.

Mansioni

• Lead global post‑marketing case processing from intake to closure.
• Develop and own pharmacovigilance workflows and work instructions.
• Establish quality review frameworks for case processing.
• Ensure compliance with GVP, FDA requirements, and SOPs.
• Act as SME and negotiate with clients; mentor others.

Conoscenze

Drug safety

Pharmacovigilance

Leadership

Communication

Problem solving

Formazione

PharmD

PhD

Masters

Strumenti

MS Office

Safety databases

Descrizione del lavoro

MMS Holdings Inc is seeking a senior pharmacovigilance leader to oversee global post‑marketing case processing from intake to closure. You will develop PV workflows and ensure GVP/FDA compliance while serving as SME for clients and mentoring teams.

Applicants should have deep knowledge of ICH guidelines, pharmacovigilance systems, and regulatory expectations, enabling strategic input across projects and client interactions.