Senior Manager, Pharmacovigilance Scientist

The Role :  ModernaTX, Inc. seeks a Senior Manager, Pharmacovigilance Scientist for its Cambridge, Massachusetts location.Here’s What You’ll Do :  Provide specialized pharmacovigilance support for Moderna’s developmental products and advancing the company’s innovative messenger RNA approach to drug development.Work to ensure the safety and efficacy of Moderna's products across their lifecycle. Provide detailed, critical analysis and drive projects to completion in a fast-paced, evolving environment. Review and provide pharmacovigilance therapeutic area input into a variety of critical documents, such as development protocols, Investigator Brochures, Statistical Analysis Plans, Clinical Study Reports, and others. Review and actively contribute to the safety aspects of documentation, ensuring they are in line with regulatory requirements and best practices in patient safety. Review and provide pharmacovigilance input for investigator brochures, study protocols, and other clinical documents. Represent the pharmacovigilance function on clinical teams and initiatives, both within and across functional areas, fostering cross-functional collaboration. Facilitate Safety Review Committee meetings, coordinate signal evaluation and safety review activities, and participate in the evaluation of potential safety issues. Utilize MedDRA (Medical Dictionary for Regulatory Activities) to accurately code and interpret safety data in regulatory communications and adverse event reports, ensuring consistency and accuracy in medical terminology across all pharmacovigilance documentation and regulatory submissions, and synthesizing and communicating complex safety information. Utilize Tableau to create data visualizations, making complex safety data accessible to team members and stakeholders. Manage safety data and case reporting with Veeva Systems and ARISg / Argus platforms. Assist with the writing and maintenance of Safety Monitoring Plans and Safety Data Exchange Agreements, with ensure regulatory compliance and the safeguarding of patient safety. May telecommute up to 2 days per week. Here’s What You’ll Bring to the Table : Minimum requirements : Requires a Doctor of Pharmacy degree, or foreign equivalent, and at least 1 year of experience as a Post-Doctoral Fellow, Global Safety Fellow, or related position supporting pharmacovigilance safety operations. Must have at least 1 year of experience with each of the following :  Applying pharmacovigilance and drug safety knowledge to oversee drug safety; Preparing regulatory communications and reports in compliance with MedDRA terminology and classifications; Clinical document review and development; Veeva Systems and ARISg / Argus; and Data Visualization with Tableau. May telecommute up to 2 days per week.This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.Apply at https : / / modernatx.wd1.myworkdayjobs.com / en-US / M_tx (Job ID : R17312  or email resume and cover letter to careers@modernatx.com with subject line : R17312.#DNIModerna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including : Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ communityGenerous paid time off, including :

• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras! About ModernaSince 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.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.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.Moderna is a smoke-free, alcohol-free and drug-free work environment.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 proud to be an equal opportunity workplace and is an affirmative action employer.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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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.  (EEO / AAP Employer) #LI-JW2-SummaryLocation : Cambridge, Massachusetts; Medical AffairsType : Full time