Reporting to the Sr. Manager PV Operations-Global Case Management, the Sr. Specialist, PV Ops Global Case Management, supports the development and maintenance of the necessary processes to ensure high quality pharmacovigilance data capture and reporting. This individual will leverage knowledge of CFR, ICH, and EU PV legislation, MedDRA, and WHO-DD coding, to ensure high quality and compliance. This position will collaborate closely cross-functionally and cross-regionally. This is an exciting time to join Moderna as we experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years. The Sr. Specialist, PV Operations Global Case Management will provide critical support to Moderna's future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform. This is an exciting opportunity to play an important and valued role as a member of the PV team at a high-growth organization that is radically changing the biotech industry and promoting global public health.
Here's What You'll Do:
Regularly monitor and manage global case management mailboxes
Communicate with vendors regarding Individual Case Safety Reports
Identify issues and collaborate with internal and external partners to come to a resolution
Schedule meetings and record minutes for multiple projects
Prepare and distribute communications and correspondence such as memos, emails, reports, meeting agendas
Support global case management in reconciliation activities
Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits. Be an active contributor during audits and inspections by preparing and reviewing responses
Participate in the development and maintenance of PV System policies, SOPs, work instructions, forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
Assist in safety database validation by performing user acceptance testing
Escalate issues to management as needed
Assist with individual projects assigned by global PV management in support of Clinical Safety and Pharmacovigilance departmental initiatives
Provide assistance for the development, maintenance, and delivery of training materials for internal and external groups, as needed
Here's What You'll Bring to the Table:
Bachelor's degree preferably in life science, nursing, pharmacy, or other healthcare related profession
Minimum of 2-3 years of direct pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization
Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems
Knowledge of GCPs, ICH guidelines and FDA, EMA, MHRA, PMDA, and Health Canada and other international regulations and guidelines
Working knowledge of MedDRA and WHO Drug dictionaries
Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
Detail-oriented, with good organizational, prioritization of competing requests/projects, and time management proficiencies. Must be able to work on multiple projects simultaneously and independently
Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
Proficient in standard computer software (Word, Excel, and Power point presentations)
Outstanding communication skills (verbal and written)
Ability to manage multiple projects in a fast-paced environment
Ability to effectively collaborate in a dynamic, cross-functional matrix environment
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)
