Senior Manager, Pharmacovigilance Scientist

The Role:

ModernaTX, Inc. seeks a Sr. Manager, Pharmacovigilance Scientist for its Cambridge, Massachusetts location.

Here’s What You’ll Do:

• Provide therapeutic area Pharmacovigilance support and representation for developmental products in close collaboration with Medical, Clinical, Regulatory, Epidemiology, Data Management, and Biostatistics stakeholders.

• Partner with Pharmacovigilance physicians to provide Pharmacovigilance and clinical expertise and support for deliverables and activities related to signal management and drafting of responses to regulatory inquiries on product safety issues for assigned products, during all phases of the product life-cycle.

• Review safety sections and provide safety content for study protocols, statistical analysis plans, and other clinical study-related documents as well as standard design of tables, figures, and listings for safety data from clinical studies.

• Support data analytics for product submission activities for clinical trials including Investigator Brochures, Company Core information, and other Reference Safety information.

• Review clinical and post-marketing Safety data and scientific literature for safety information.

• Contribute to Safety contents for aggregate reports and Risk Management plans.

Here’s What You’ll Bring to the Table:

Minimum requirements:

• Requires a Master’s degree, or foreign equivalent, in Pharmacology or related life science field and 6 years of experience as a Pharmacovigilance Scientist or related position providing pharmacovigilance support.

• 6 years of experience must include:

  • Adverse event analysis and signal detection;

  • Interpreting clinical data and assessing its relevance to drug safety;

  • Review of safety sections of clinical study-related documents, including study protocols, statistical analysis plan, and electronic Case Report Form (eCRF);

  • Preparation and submission of regulatory documents;

  • Preparation of aggregate reports including review of Periodic Benefit-Risk Evaluation Reports and safety summary reports; and

  • Utilizing clinical database Medidata Rave, and safety database ARGUS to conduct analysis and identify safety issues and signals.

  • This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R18079) or email resume and cover letter to careers@modernatx.com with subject line: R18079.

#DNI

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

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. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Our Working Model 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

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, please apply!

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 leavesandaccommodations@modernatx.com. 

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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