**The Role**:
Moderna is seeking a Director to lead all Pharmacovigilance Operations for Latin America under the oversight of the Senior Director, PV Operations
- Rest of World (ROW). This role will coordinate all activities required to ensure a high standard of pharmacovigilance operational collaboration with National Regulatory Agencies. This position will set oversee business partners and vendors that support PV-related activities and support regional/global initiatives to enable inspection readiness and operational efficiencies. The Latin America Country Cluster Lead will work closely and cross-functionally with other leaders in the region and globally with other Clinical Safety and PV leaders to ensure global alignment and local compliance.

This is an exciting time to join Moderna to build and establish an industry-leading PV team in Latin America as we launch our COVID-19 vaccine (mRNA 1273) globally to hundreds of millions of patients and experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years. This role will be a key contributor and a key PV leader overseeing all of our Clinical Safety and PV efforts in support of ensuring patient safety for everyone who receives Moderna’s experimental and authorized products. In addition, this role will have the opportunity to make critical contributions to Moderna’s future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

**Here’s What You’ll Do**:
Provide dynamic leadership, coordination, and close oversight of all pharmacovigilance activities in Latin America across Moderna’s portfolio and throughout the clinical development and post-marketing phases of the life cycle including:
Define the strategic coordination of PV activities within the region, develop a short, medium, and long-term action plan to fulfill this strategy

Carry out project deliverables in collaboration with cross-functional partners to ensure the delivery of global and regional objectives

Ensure regional compliance with all PV reporting obligations

Ensure PV inspection readiness and take a lead role in ensuring successful inspections, internal PV audits, and business partner PV audits.

Maintain robust quality management systems and business continuity plans for PV operations.

Closely oversee all vendors and partners in Latin America Region who perform PV activities on behalf of Moderna.

Engage externally to ensure ongoing benchmarking and the leveraging of best practices.

**Here’s What You’ll Bring to the Table**:
Bachelor's degree (preferably in a science or health related field) and a minimum of 10 years of experience in Pharmacovigilance, with at least 3 years of experience in Pharmacovigilance in Latin America.

Proven experience of PV management/oversight in LATAM countries

Prior experience in ICSR case processing, aggregate safety reporting, PV quality management systems, and PV compliance

Solid knowledge of PV intelligence

Experience working with CROs, vendors, and relationship management.

Strong project management skills and ability to partner closely and effectively cross-functionally and cross-regionally.

Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.

Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.

Ability to manage multiple projects in a fast-paced environment.

Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management)

Fluent in Spanish & Portuguese (desired)

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary winter break
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities,