The Role:Join Moderna and make a significant impact on the overall success of our novel messenger RNA approach to drug development. Reporting to the Head of Pharmacovigilance Operations, the Sr. PV Scientist will provide critical PV quality and operational support for all Moderna products throughout the life cycle. In this new role, the successful candidate will be responsible for the oversight of PV activities, vendor and alliance management, and ongoing process improvement.Here's What You'll Do:Providing therapeutic area PV support for Moderna's developmental products in close collaboration with senior PV, Clinical and Medical personnel.Oversight of day-to-day PV operational activities for Moderna's investigational products.Develop and maintain processes that will ensure excellence in global case reporting and assessment, demonstrating accuracy, consistency, and compliance with applicable global pharmacovigilance regulations.Oversight of vendor case management and continued process improvement.Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.RepresentPharmacovigilance on clinical teams and initiatives both within and across functional areas.Assist in usual pharmacovigilance activities including ongoing signal monitoring, benefit/risk assessment, regulatory activities, and interactions.Facilitate cross-functional Safety Review Committee meetings, including coordinating aspects of signal evaluation/safety review activities.Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate.Participate in writing of aggregate safety reports (e.g., DSURs), as required.Participate in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.Assist with writing and maintenance of Safety Monitoring Plans and Safety Data Exchange Agreements.Oversight of signal evaluation/safety monitoring activities.Assure oversight for the review of safety events to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.Involved in contributing to decisions regarding safety evaluation that directly impact departmental performance and regulatorycompliance." Collaborateswithcross-functionalteams to integrate Pharmacovigilance into relevant documents development, regulatory affairs, and medical affairs." Here's What You'll Bring to the Table:Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry backgroundMinimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 4 years' experience in PV – experience in vaccine development a plusKnowledge of MedDRA terminology and its applicationExperience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety informationExperience in the preparation and authoring of individual and aggregate safety reportsDemonstrated ability to develop, execute and follow-through complex projects to completionSkilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of viewIndependently motivated, detail oriented and strong problem-solving abilityExcellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing prioritiesExcellent written and verbal communication skills with the ability to interact across multiple functionsModerna 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 classesExclusive 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 parents401k 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 peopleare 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.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 make a request to the Talent Acquisition Partner or contact the Accommodations team at ****** . (EEO/AAP Employer) #LI-JW2-
