Reporting to the Sr. Manager, PV Operations Global Case Management, the Manager, PV Operations Global Case Management will provide oversight of the PV case management activities for safety reporting including the collection, processing, reporting/submission, follow-up, and reconciliation of safety information for all Moderna products (investigational and commercial). The Manager, PV Operations Global Case Management will participate in the set-up and development of monitoring tools and maintenance of case management workflows within the global safety database to meet global regulatory reporting requirements. In addition, the Manager PV Operations Global Case Management, will assist with the case readiness for internal and external reports (PSURs, PADERs, etc.). The Manager, PV Operations Global Case Management will assist in special projects as assigned. This leader 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. This role will be a key contributor and will have the opportunity to make critical contributions to Modernas future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.
Heres What Youll Do:
Ensure compliance with procedures and reporting timelines
Manage and be able to prioritize multiple projects, tasks, and other competing requests
Assist in the development, maintenance, and deliverance of training materials for internal and external groups, as needed
Provide direction and guidance to Safety Associates supporting global case management, including but not limited to activities such as:
o Mailbox management
o Cross functional collaborations
o Supporting PV tools
o Interacting with Contract Resource Organizations
Collaborate with key stakeholders to monitor and drive effective and timely case follow up workflows that are aligned and integrated with procedures
Support PV Operations activities during audits and inspections in the areas of case management, vendor oversight, etc.
Assist with individual projects assigned by global PV management in support of Clinical Safety and Pharmacovigilance departmental initiatives
Review documents related to safety case processing and reporting such as Safety Management Plan, reconciliation plan, data handling conventions, Safety Data Exchange Agreements (SDEAs), and PV agreements with partners, vendors, and other third parties
Drive and manage initiatives to improve quality of ICSRs and compliance
Contribute on behalf of CSPV to presentations, discussions, and data summaries on safety issues at meetings with external and internal partners
Provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards
Escalate issues to management as needed
Assist in the preparation of ICSR health authority responses
Heres What Youll 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 6 years of direct pharmacovigilance experience
Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems. Previous experience and formal training with safety database programs including configuration and validation activities is desired.
Commitment to and experience in evaluating and implementing innovative digital solutions in PV operations including automation and machine learning.
Knowledge of GCPs, ICH guidelines and FDA, EMA, MHRA, PMDA, and Health Canada and other international regulations and guidelines (participation in inspections and audits)
Working knowledge of MedDRA and WHO Drug dictionaries
Experience with onboarding, oversight, and management of safety vendors
Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
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)
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!
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.
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. Were 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at email@example.com. (EEO/AAP Employer)