LATAM Pharmacovigilance Cluster Lead

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

Job summary

ModernaTX, Inc. seeks a Cluster Lead, Pharmacovigilance, LATAM in Cambridge, MA to oversee PV operations across multiple LATAM countries, ensuring compliance with local and international regulations and defining the regional PV strategy with short-, mid-, and long-term plans.

You will lead audits and inspections readiness, manage safety data exchange agreements with vendors, review PSURs/RMPs, collaborate with Regulatory Affairs, Commercial, and Clinical Development, and ensure PV is embedded

Qualifications

• Master’s degree or foreign equivalent in Pharmaceutical Sciences or related field.
• 8 years of PV leadership roles with LATAM regulatory engagement.
• Experience with ICSR, PSURs, RMPs, and PV SOPs; Veeva/Argus preferred.
• Willingness to travel up to 15% domestically and internationally.

Responsibilities

• Oversee end-to-end PV operations across LATAM with regulatory alignment.
• Develop and implement PV strategy and short-/mid-/long-term plans for the region.
• Engage with health authorities and CROs; manage PV agreements with vendors.
• Ensure PV quality systems, inspection readiness, and global alignment.

Skills

PV leadership LATAM

Regulatory engagement

ICSR processing

Vendor management

PV systems & quality

Education

Master's degree in Pharmaceutical Sciences

Bachelor's degree in related field

Tools

Veeva Safety

Argus

Job description

ModernaTX, Inc. seeks a Cluster Lead, Pharmacovigilance, LATAM in Cambridge, MA to oversee PV operations across multiple LATAM countries, ensuring compliance with local and international regulations and defining the regional PV strategy with short-, mid-, and long-term plans.

You will lead audits and inspections readiness, manage safety data exchange agreements with vendors, review PSURs/RMPs, collaborate with Regulatory Affairs, Commercial, and Clinical Development, and ensure PV is embedded