Director, PV Operations - Global Case Management, Global Submissions
ModernaTX, Inc.

The Role:

Reporting to the Senior Director of Global PV Operations, Global Case Management the Director, PV Operations, Global Submissions; will be accountable for the execution of Moderna's Individual Case Safety Reports (ICSR) Submissions 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 Pharmacovigilance. This position will work closely with Moderna's Digital 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. This is an exciting time to join Moderna as we launch our COVID-19 vaccine (mRNA 1273) globally 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 critical 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'll Do:

Primarily responsible leading submissions for clinical trial and postmarketing cases globally.This includes providing technical guidance and direction to our safety database vendors. . Examine, evaluate, and investigate eligibility for, or conformity with, laws and regulations governing compliance of licenses and permits, and perform other compliance and enforcement inspection and analysis activities for pharmacovigilance.

Provide dynamic leadership, strategic direction, and global oversight of key pharmacovigilance operations activities across Moderna's portfolio and throughout the clinical development and post-marketing phases of the life cycle including:

• Implement systematic process and procedures for oversight of the vendor supporting ICSR submissions and follow-up query process to ensure compliance with global health authorities and Moderna's guidelines.
  
• Provide strategic direction and oversight of processes and develop guidance documents supporting the global query management and global submissions responsibilities.
  
• Monitors follow-up activities performed by support staff, such as:
  
  • Ensures the quality of outgoing queries (post-marketing and clinical) are in compliance with Moderna standards and guidelines
    
  • Ensures accuracy of queries questions, along with management and escalation of clinical queries
    
• Ensuring ICSR inspection readiness across the organization, working closely with our Quality team, and serving as a key senior PV leader during major PV inspections
  
• Will be accountable for all the reports and submissions of ICSRs for the company's products covering pre and post marketing activities.
  
• Supports the reporting system 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.
  
• Responsible for the set-up and development of monitoring tools and maintenance of submissions workflow within the global safety database to meet global regulatory reporting requirements.
  
• Responsible for monitoring and tracking local country specific ICSR submissions within the global safety database.
  

• Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of major regulatory submissions.
  
• In conjunction with the compliance team support the escalation and investigation of safety and non-compliance issues and identify root causes for late ICSR submissions and implementation of appropriate corrective actions.
  
• Assess impact of new regulations on the safety database reporting rules and oversees updates as appropriate
  
• Assess impact of new product configuration and management of product licenses
  
• Continuously assess global PV regulations to ensure compliance.
  
• Help lead Moderna's efforts in PV Innovation and Automation in close partnership with our Digital organization.
  
• Develop training plans and competency assessments for all aspects of ICSR management and ensure appropriate delivery internally and externally
  
• Interacts on a regular basis with contracted vendors supporting GPV (Clinical Research Organization, data management, product quality, call center, etc.) 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 other members of GPV to support monitoring of oversight reports and procedures.
  
• Contribute to development and maintenance of Safety Management Plans (SMPs) and PV agreements with partners, vendors, and other third parties
  
• Engage externally to ensure ongoing benchmarking and the leveraging of best practices.
  

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 10 years of direct pharmacovigilance experience in Biotech, Pharma, or a Clinical Research Organization.
  
• Extensive prior experience in ICSR case processing, PV quality management systems, and PV compliance (including major PV inspections)
  
• Commitment to and extensive experience in evaluating and implementing innovative digital solutions in PV operations including automation and machine learning; seeking to create patentable ideas
  
• Solid knowledge of ICH guidelines relevant to PV and of global PV regulations, including FDA, EMA, MHRA, PMDA, and Health Canada
  
• Significant experience working with CROs, vendors, and relationship management.
  
• Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
  
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
  
• Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks while working in a matrixed environment.
  
• Ability to manage multiple projects in a fast-paced environment.
  
• Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management)
  
• Oversight experience of global PV operational activities in pre and post marketing environments.
  

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 winter shut down
  • 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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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