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!