Senior Pharmacovigilance Physician - Global Safety Lead

MMS; Austin (TX); Vor Ort; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

MMS is a data-driven CRO seeking a Senior Pharmacovigilance Physician to lead signal management and safety surveillance across trials and regulatory submissions. The role requires independent medical judgment, strong communication with clients, and leadership in safety deliverables.

Ideal candidates possess an MD/DO, 5+ years in pharmacovigilance, and proficiency with MeDRA/WHODRUG, DSURs, and regulatory standards.

Qualifikationen

• MD/DO degree required; board certification preferred.
• Minimum 5 years in pharmacovigilance, safety signal detection or related roles.
• Strong knowledge of ISO standards and FDA/GCP requirements.

Aufgaben

• Lead end-to-end signal management and safety surveillance activities.
• Provide medical review for safety issues and regulatory submissions.
• Mentor junior staff and coordinate with clients on safety deliverables.
• Represent MMS in safety discussions with clients and internal teams.

Kenntnisse

Signal management

Safety surveillance

MeDRA/WHODRUG

DSUR/PADER/BSUR

Medical review

Client communication

Risk assessment

Regulatory updates

Safety deliverables

Mentorship

Medical monitoring

Ausbildung

MD/DO

Board certification preferred

Tools

MS Office

Regulatory databases

Jobbeschreibung

MMS is a data-driven CRO seeking a Senior Pharmacovigilance Physician to lead signal management and safety surveillance across trials and regulatory submissions. The role requires independent medical judgment, strong communication with clients, and leadership in safety deliverables.

Ideal candidates possess an MD/DO, 5+ years in pharmacovigilance, and proficiency with MeDRA/WHODRUG, DSURs, and regulatory standards.