Sr. Manager, PV Operations, Global Submissions

The Role:

Reporting to the Director of PV Operations – Global Submissions; the Senior Manager, PV Operations - Global Submissions will be accountable for the execution of Moderna’s Individual Case Safety Reports (ICSR) Submission’s activities worldwide. This position leads the development, documentation, implementation and maintenance of the processes and standards required to ensure Moderna maintains the highest global standards of ICSR quality and compliance with global health authority regulations. This experienced Pharmacovigilance leader will use their broad and comprehensive understanding of the health authority systems worldwide to lead and influence our global PV vendors in high quality case submissions and simplified processes. The position will liaise with groups both internal and external to Global Case Management (GCM). This position will work closely with Moderna’s PV Digital Innovation team and others across Clinical Safety and Pharmacovigilance to drive the implementation of advanced, validated, automated solutions. This position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally.

Here’s What You’ll Do:

Responsible for leading global submissions for both clinical trial and post-marketing cases, providing technical guidance, and ensuring compliance with laws and regulations.

• Lead key pharmacovigilance operations activities globally, implementing systematic processes for oversight of the vendor supporting Individual Case Safety Report (ICSR) submissions.

• Provide strategic direction and oversight of global query management and submission responsibilities, ensuring compliance with global health authorities and Moderna's guidelines.

• Ensure ICSR inspection readiness across the organization, working closely with Compliance Alliance and Process Excellence (CAPE) team, and serve as a PV leader during major PV inspections.

• Accountable for all the reports and submissions of ICSRs for the company’s products covering pre- and post-marketing activities.

• Support the reporting systems of the CSPV department which includes managing the safety report schedule and reporting rules.

• Responsible for maintaining compliant and core safety documents, planning all updates scheduling and carrying out all submissions within applicable regulatory timelines.

• Develop monitoring tools and maintain submissions workflow within the global safety database to meet regulatory reporting requirements.

• Monitor and track local country specific ICSR submissions and assess the impact of new regulations on safety database reporting rules.

• Proactively identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of major regulatory submissions.

• Support the escalation and investigation of safety and non-compliance issues, identifying root causes for late ICSR submissions, and implementing corrective actions.

• Assess impact of new regulations on the safety database reporting rules and oversee updates as appropriate.

• Assess the impact of new product configuration and management of product licenses.

• Continuously assess global PV regulations to ensure compliance.

• Lead Moderna’s efforts in PV Innovation and Automation in close partnership with PV Digital Innovation team.

• Support development of training plans and competency assessments for ICSR management and ensure appropriate delivery internally and externally.

• Regularly interact with contracted vendors to resolve pharmaceutical safety-related issues.

• Participate in the development and maintenance of PV System policies, SOP forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.

• Collaborate with GCM members to support monitoring of oversight reports and procedures.

• Contribute to development and maintenance of Safety Reporting Plans (SRPs), and PV agreements with partners and vendors.

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

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy, or other healthcare related profession (RN, PharmD, NP, PhD, MPH, etc.).

• Minimum of 8 years of pharmacovigilance experience in Biotech, Pharma, or a Clinical Research Organization.

• Extensive prior experience in ICSR case processing, submissions, PV quality management systems, and PV compliance (including major PV inspections).

• Commitment to evaluating and implementing innovative digital solutions in PV operations, including automation and machine learning.

• Solid knowledge of ICH guideline