The Role:
ModernaTX, Inc. seeks a Cluster Lead, Pharmacovigilance, LATAM for its Cambridge, Massachusetts location.
Here’s What You’ll Do:
- Responsible for end-to-end oversight of pharmacovigilance (PV) operations across multiple Latin American countries, including the implementation and continuous improvement of PV systems to ensure compliance with local and international regulatory requirements.
- Provide dynamic leadership and strategic oversight of PV operations in Latin America, ensuring excellence in execution, and define the PV strategy for the region and develop actionable short-, medium-, and long-term plans to achieve safety and compliance goals.
- Engaging with local Health Authorities to understand, interpret, and align Moderna’s safety reporting processes with country-specific legislation, particularly in a region where regulatory frameworks are actively evolving.
- Establish governance and operational processes with business partners and vendors, including the development of safety data exchange agreements and procedures for case processing, reconciliation, and audit preparedness.
- Regularly coordinate with global teams to ensure the exchange of safety information meets internal standards and regulatory expectations.
- Develop and review Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs/PBRERs), and local literature screening strategies.
- Collaborate with cross-functional internal teams such as Regulatory Affairs, Commercial, and Clinical Development to ensure PV is embedded throughout the product lifecycle.
- Deliver cross-divisional projects that strengthen collaboration with global teams and support corporate safety objectives.
- Ensure full regional compliance with PV reporting requirements and regulatory expectations.
- Lead PV inspection readiness efforts and participate in internal audits and external inspections by partners and health authorities.
- Maintain and continuously improve a robust PV Quality Management System and Business Continuity Plan.
- Oversee the performance and compliance of vendors and partners executing PV activities on behalf of Moderna across the region.
- Engage with external stakeholders to benchmark and implement best practices in pharmacovigilance.
- Participate in regional safety vendor qualification, internal and external audits, and quality management activities to uphold safety and compliance standards.
Here’s What You’ll Bring to the Table:
Minimum requirements:
- Requires a Master’s degree or foreign equivalent in Pharmaceutical Sciences or a related field and 8 years of experience as a Pharmacovigilance Lead, Senior Pharmacovigilance/Drug Safety Specialist, or related position supporting pharmacovigilance operations.
- Alternatively, employer will accept a Bachelor’s degree, or foreign equivalent, in the fields specified and 10 years of specified progressive, post-baccalaureate experience.
- 8 years of experience must include:
- Pharmacovigilance oversight and regulatory engagement for the LATAM region applying Good Pharmacovigilance Practices for the Americas and local PV regulations for Mexico, Argentina, Brazil, Paraguay, Colombia, Panama, Peru and Chile;
- Individual Case Safety Report (ICSR) processing, aggregate safety reporting, Pharmacovigilance Quality Management Systems, and compliance;
- Ensuring timely and accurate safety data management, maintaining robust quality systems, and aligning regional LATAM pharmacovigilance operations with global regulatory standards;
- Working with Contract Research Organizations (CROs), vendors, business partners and stakeholders across cross-functional teams to ensure aligned pharmacovigilance operations;
- Veeva Safety and Argus; Risk Management Plans (RMP), Periodic Safety Updated Reports (PSUR), and development of Standard Operating Procedures (SOPs) and Pharmacovigilance Agreements (PVA); and
- Pharmacovigilance Management for business partners and vendors.
- Position requires up to 15% domestic and international travel, fully reimbursed.
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