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(Contract) Sr. Manager, ICSR Quality, Pharmacovigilance Operations at Moderna Therapeutics in Cambridge, Massachusetts

Posted in Other 30+ days ago.





Job Description:

The Role:

Moderna is seeking a Sr. Manager of ICSR Quality, Pharmacovigilance Operations, to provide key operational support throughout the lifecycle of Moderna's products. The successful candidate will lead Moderna's PV Operations team in providing oversight of PV vendor case processing quality.

Here's What You'll Do:


  • Develop and implement a Quality Oversight plan for systematic, internal ICSR quality review in Moderna's global safety database to include documentation of reviews and providing feedback to vendors.


  • Lead and manage PV Operations ICSR quality review activities across the company platform


  • Aid in the development and maintenance of training materials for case processing teams.


  • Define key metrics for oversight of ICSR quality and vendor performance


  • Establish successful working relationships with and provide oversight to PV Vendors/CROs with day-to-day PV operational activities impacting/potentially impacting ICSR quality.


  • Ensure overall performance of the department and compliance with global regulatory requirements by assisting in implementation of applicable SOPs, processes, metrics, and monitoring of performance and compliance.


  • Collaborates with other key stakeholders to provide expertise and guidance for interdepartmental and cross-functional team activities, including process improvement standards.


  • Provide training to internal and external groups, as needed.


  • Support PV Operations activities during audits and inspections in the areas of case processing/case management activities, metrics, vendor oversight, etc.


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


  • Bachelor's degree required. Candidates with a background in healthcare and/or extensive PV experience preferred.


  • Minimum of 6 years of recent experience in pharmacovigilance/drug safety or relevant scientific/clinical or pharmaceutical experience.


  • Detailed knowledge of 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


About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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.

#LI-DNI

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