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2023 Intern, Clinical Safety Science

The Role:
Moderna is seeking a highly skilled, talented, and motivated student to support activities related to clinical safety and the Pharmacovigilance Clinical Safety Science team. This is a new opportunity for a candidate to develop skills and learn about the biopharmaceutical industry, Moderna, and product safety and PV Safety Science in a supportive environment. We are seeking a candidate who is aligned with Moderna’s culture centered on bold, collaborative, curious, and relentless values, which enable innovation in mRNA-based vaccines and therapeutics to benefit patients. The ideal candidate will work closely with the Pharmacovigilance Safety Science team leads to help contribute to Moderna’s future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform.

Our program offers one start date on Monday, June 5. All applicants must be available for a minimum of 10 weeks to participate in the program.

Here’s What You’ll Do:
  • Develop an understanding of the current PV Safety Science landscape to help support the strategic direction of the PV Safety Sciences team
  • Support review of adverse event data, literature review and other safety-related data for the purpose of signal detection
  • Learn activities assessing data for early signals, data assessment and tracking in compliance with worldwide signal management regulations. 
  • Gain an understanding of the relationships and dependencies between signal management and documents/analyses produced for regulators (FDA, EU) across the development of periodic or other annual reports and/or deliverables
  • Understand applicable regulatory intelligence on global regulations/guidance documents
  • Collaborate with internal stakeholders, including physicians, safety scientists and medical colleagues, to review safety data for signal assessments
  • Understand the key roles and responsibilities of compliance and quality and the intersection of the key concepts required to help support Safety Science
  • Identify and map the end-to-end process as it relates to identified projects– from development to execution, including the identification of key subject matter experts and functions that are critical to the process
  • Engage cross-functionally within the organization to develop leadership skills and align with business objectives
  • Assist in review of worldwide medical/scientific literature to identify signals and applicable information
  • Gain exposure and handling of the digital signal detection tool and assist in the conduction of signal detection reviews using innovative signal detection methods
  • Partner with various teams across Pharmacovigilance Safety Science in order to support users with multiple perspectives and different levels of user experience in Pharmacovigilance Operations
  • Gain an understanding of FDA and EMA regulations, ICH guidelines, Good Clinical Practices, and the drug development process
  • Learn practical application of theoretical skills
  • Learn to working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

Here’s What You’ll Bring to the Table:
  • A curiosity and desire to learn more about the biopharmaceutical industry from industry experts
  • Be enrolled in a degree program focused on the sciences, including but not limited to biopharmaceutical sciences, technology, project management, health care professional (e.g. nursing, PharmD), STEM, Business, HR, public health or similar
  • Excellent communication skills (written and spoken), and strong interpersonal and time-management skills
  • Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
  • Boldness to ask relevant questions to identify opportunities for continuous improvement and to support creative problem solving
  • Strong analytical skills to translate data and information into a strategy for action
  • An eagerness to work with all levels of management and consult with key business stakeholders
  • Proficiency with MS Office Suite and a comfort with learning technical tools/systems relevant to the job function

Moderna is pleased to provide you with an innovative suite of benefits, including:
  • Free premium access to meditation and mindfulness classes
  • Free parking or subsidized commuter passes
  • Generous paid time off, including:
  • Vacation, sick time and holidays
  • Volunteer time to participate within your community
  • Discretionary winter shut down
  • Location-specific perks and extras!