Associate Director, Pharmacovigilance Scientist
1 month ago
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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-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.
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. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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