Cluster Lead, Pharmacovigilance, LATAM

Moderna Therapeutics; Cambridge (MA); Vor Ort; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

PV leadership LATAM

Regulatory engagement

ICSR processing

Vendor management

PV systems & quality

Ausbildung

Master's degree in Pharmaceutical Sciences

Bachelor's degree in related field

Tools

Veeva Safety

Argus

Jobbeschreibung

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.

#DNI About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day,

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Our Mission and Vision

At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.