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Associate Director, Pharmacovigilance Scientist, Infectious Diseases

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Feb 23, 2024

Job Details

The Role:

Join Moderna Therapeutics enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. Reporting to the Senior Director of Pharmacovigilance, the PV Scientist will be a key contributor focusing on strategic input, support in clinical trial, perform signal management activities and operational support for all Moderna products throughout the life-cycle. In this new role, the successful candidate will be responsible for the oversight of PV activities, vendor and alliance management, and ongoing process improvement.

Heres What Youll Do:

  • Providing therapeutic area PV support for Modernas developmental products in close collaboration with senior PV, Clinical and Medical personnel.

  • Oversight of day to day PV operational activities for Modernas investigational products.

  • Develop and maintain processes that will ensure excellence in global case reporting and assessment, demonstrating accuracy, consistency and compliance with applicable global pharmacovigilance regulations.

  • Oversight of vendor in case management and aggregate reports.

  • Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.

  • Represent Pharmacovigilance on clinical teams and initiatives both within and across functional areas.

  • Assist in usual pharmacovigilance activities including ongoing signal monitoring and regulatory activities.

  • Facilitate cross-functional Safety Review Committee meetings, including coordinating aspects of signal evaluation/safety review activities.

  • Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate.

  • Participate in writing of aggregate safety reports (e.g., DSURs), as required.

  • Participate in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.

  • Assist with writing and maintenance of Safety Monitoring Plans and Pharmacovigilance Agreements.

  • Oversight of signal evaluation/safety monitoring activities.

  • Assure oversight for the review of aggregate safety data to ensure accuracy, integrity and completeness.

  • Collaborate with PV colleagues to find solutions to complex problems.

  • Assure high quality on time deliverables.

  • Partner with internal and external colleagues

Heres What Youll Bring to the Table:

  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background

  • Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 4 years experience in PV experience in vaccine development is required

  • Knowledge of MedDRA terminology and its application

  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information

  • Experience in the preparation and authoring of individual and aggregate safety reports

  • Demonstrated ability to develop, execute and follow-through complex projects to completion

  • 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

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, 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

#LI-DNI

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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