Sr. Manager, Pharmacovigilance Reporting at ModernaTX, Inc.

Posted in Other 12 days ago.

Location: Cambridge, Massachusetts





Job Description:

The Role:



Reporting to the Head of Digital Innovation in the Pharmacovigilance Operations group, this individual experienced in the Pharmacovigilance (PV) reporting landscape will design, manage, and lead the data output from our state-of-the-art Signal Management, Analytics and Reporting Tool. This will require ensuring the data output is aligned with the regulations and the associated configurations identified within our safety database and our Signal Management platforms. The candidate will support the management of multiple competing priorities and be able to pivot fearlessly to remain synchronized with our Moderna Digital Transformation across Clinical Safety and Pharmacovigilance (CSPV). The candidate will effectively partner with teams across CSPV and with external vendors to ensure system and report requirements are well understood, communicated, and accurately implemented. This position will support organizational objectives and assist in the uptake of new reports to address Health Authority requests and inspection responses in addition to the support and training of individuals on existing reports. This individual will also partner with the Associate Director to contribute to a change management plan which considers effective implementation and efficient utilization of innovative technology for multiple stakeholders in the Signal Management, Analytics and Reporting arena.


This is an exciting time to join Moderna as we prepare to progress the deep portfolio of our mRNA platform 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 will have the opportunity to make significant 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 will Do



  • Develop, manage, and lead implementation of Signal Management reporting requirements and output necessary for alignment with global Health Authority guidelines and inquiries.


  • As a member of the Digital Innovation team, this individual will support risk identification efforts and mitigation measures to ensure delivery of initiatives on time and on budget.


  • Work collaboratively to define our short- and long-term roadmap to achieve efficiency and cost savings in line with Moderna's bold digital vision.


  • Ability to effectively and succinctly communicate complex technical concepts and future enhancements aligned with driving efficiencies, compliance, and stellar quality across the Pharmacovigilance toolkit.


  • Support the activity of overseeing the reporting within the global Signal Management ecosystem under the guidance of senior leadership to ensure the output is in an inspection-ready state.


  • Partner with the Clinical Safety & Risk Management teams to design and implement a change management plan for the users ensuring that multiple perspectives and levels of user experience are considered.


  • Assist in evaluating current reporting requirements and contribute to cross-functional team efforts to develop output for Moderna in alignment with Audit and Health Authority needs.


  • Ensure uptake of Signal and Analytics platforms to further drive efficiencies across the Signal Management space within the enterprise.





Here's What You Will Bring to the Table:



  • Bachelor's degree (preferably in a technology related field) and a minimum of 5-7 years of experience in Pharmacovigilance Operations in Biotech, Pharma, a Clinical Research Organization, or Consultancy.


  • Prior considerable experience managing implementation and steady state PV Digital Solutions with particular focus on Signal Management, Analytics and Reporting tools.


  • Proven leadership evaluating and implementing innovative digital solutions and the required change management elements for adoption of the technology.


  • Experience with digital project management and implementation


  • Ability to serve as a consultant with key business stakeholders, including an ability to influence to achieve success.


  • Commitment to evaluating and implementing innovative digital solutions in PV operations, including automation, artificial intelligence, and large language models.


  • High quality standards for PV Systems to ensure data accuracy and integrity.


  • The ability to be self-motivated to understand current pharmacovigilance needs and how to address these needs within the technical ecosystems of the global enterprise.


  • Desire to push past possible to deliver best in class capabilities within the Signal Management area.





Moderna 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 options

  • Flexible Spending Accounts for medical expenses and dependent care expenses

  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities

  • Family care benefits, including subsidized back-up care options and on-demand tutoring

  • Free premium access to fitness, nutrition, and mindfulness classes

  • Exclusive preferred pricing on Peloton fitness equipment

  • Adoption and family-planning benefits

  • Dedicated care coordination support for our LGBTQ+ community

  • Generous 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 thereafter

  • Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

  • 401k match and Financial Planning tools

  • Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

  • Complimentary concierge service including home services research, travel booking, and entertainment requests

  • Free parking or subsidized commuter passes

  • 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.


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)


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