Reporting to the Associate Director, PV Operations Global Case Standards and Quality Analytics, the Sr. Manager, PV Operations - ICSR Quality will be responsible for effective execution of the activities of in-line and retrospective quality review of individual case safety reports (ICSR) from Moderna clinical trials and post-market sources to ensure timely and accurate assessment of adverse event reports. This individual will work with the Associate Director, PV Operations ICSR Quality to coordinate quality review activities across the global team. This role will focus on quality control and ensuring the highest quality of case processing. This person will work together with the Global PV Operations team to identify quality trends and implement quality improvement solutions; setting priorities for areas that require improvement. 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.
Here's What You'll Do:
Here's What You'll Bring to the Table:
- Perform internal ICSR quality review during inline case processing and perform routine retrospective quality review in Moderna's global safety database and provide timely feedback to the vendor(s).
- Perform routine monitoring of ICSR quality issues in the designated mailbox to track ICSR quality and vendor performance while supporting Associate Director, PV Operations ICSR Quality Analytics in the data analysis and the development of monthly metrics.
- Liaise with key partners and other stakeholders regarding safety data collection and data reconciliation
- Aid in the development and maintenance of training materials for case processing teams, support audits and inspections as needed, and perform ICSR case processing activities as a backup support for select ICSRs as assigned.
- Establish successful working relationships with and provide oversight to PV Vendor(s) with day-to-day PV operational activities impacting/potentially impacting ICSR quality.
- Perform ICSR case processing activities as a backup support for select ICSRs as assigned.
- Aid in implementation of processes that monitor compliance with global regulatory requirements. Ensure that the rate of quality errors remain favorably low.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Candidates with a background in healthcare and PV experience preferred.
- Minimum of 6 years of recent experience in pharmacovigilance/drug safety with a Bachelor's Degree in relevant healthcare field or 8 years of relevant experience with a Master's Degree in a relevant healthcare field.
- Deep understanding of Argus safety database and strong case processing experience.
- Deep knowledge of Microsoft Excel
- Detailed knowledge and ability to apply global ICSR quality standards and direct experience performing quality reviews and providing feedback on those reviews.
- Demonstrated ability to develop, execute and follow-through complex projects to completion.
- Working knowledge of global pharmacovigilance regulations.
- Knowledge of MedDRA terminology and its application.
- Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view.
- Independently motivated, detail oriented and strong problem-solving ability.
- Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities.
- Excellent written and verbal communication skills with the ability to interact across multiple functions.
- 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!
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.