LATAM Pharmacovigilance Lead: Strategy & Compliance

Moderna Therapeutics; Cambridge (MA); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Travel up to 15%

Job summary

Moderna Therapeutics seeks a Cluster Lead, Pharmacovigilance, LATAM to oversee PV operations across LATAM with strategic leadership for safety systems and compliance. Based in Cambridge, MA, you will coordinate with global teams to ensure timely safety reporting and continuous improvement of PV programs.

You will develop and maintain RMPs, PSURs, and PV quality management, lead vendor oversight, and engage with Health Authorities to align with country regulations.

Qualifications

• Requires advanced PV oversight and regulatory engagement for LATAM.
• Experience with ICSR processing and aggregate safety reports.
• Knowledge of PV QA systems and compliance.
• Experience managing CROs/vendors and cross-functional teams.

Responsibilities

• Oversee end-to-end PV operations for LATAM, ensuring regulatory compliance.
• Lead PV strategy, governance, and vendor management across the region.
• Develop and review RMPs and PSUR/PBRERs; implement SOPs and PV agreements.
• Engage with Health Authorities and cross-functional teams to embed PV into product lifecycle.
• Lead inspection readiness and coordinate audits across the LATAM region.

Skills

PV oversight

Regulatory engagement

ICSR processing

PV QA systems

SOPs & PVA

Vendor management

Education

Master's in Pharmaceutical Sciences

Bachelor's in relevant field + 10 yrs exp

Tools

Veeva Safety

Argus

Job description

Moderna Therapeutics seeks a Cluster Lead, Pharmacovigilance, LATAM to oversee PV operations across LATAM with strategic leadership for safety systems and compliance. Based in Cambridge, MA, you will coordinate with global teams to ensure timely safety reporting and continuous improvement of PV programs.

You will develop and maintain RMPs, PSURs, and PV quality management, lead vendor oversight, and engage with Health Authorities to align with country regulations.