Sr. Manager, PV Reporting, Digital Innovation

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 provid