Sr. Specialist, PV Operations Global Case Management

The Role:

Reporting to the Sr. Manager PV Operations-Global Case Management, the Sr. Specialist, PV Ops Global Case Management, supports the development and maintenance of the necessary processes to ensure high quality pharmacovigilance data capture and reporting. This individual will leverage knowledge of CFR, ICH, and EU PV legislation, MedDRA, and WHO-DD coding, to ensure high quality and compliance. This position will collaborate closely cross-functionally and cross-regionally. This is an exciting time to join Moderna as we experience acceleration in our pipeline and late phase development, thereby poising Moderna for substantial growth in the upcoming years. The Sr. Specialist, PV Operations Global Case Management will provide critical support to Moderna’s future success in making a transformative impact to patients through our vaccines and therapeutics using our mRNA platform. This is an exciting opportunity to play an important and valued role as a member of the PV team at a high-growth organization that is radically changing the biotech industry and promoting global public health.

Here’s What You’ll Do:

• Regularly monitor and manage global case management mailboxes

• Communicate with vendors regarding Individual Case Safety Reports

• Identify issues and collaborate with internal and external partners to come to a resolution

• Schedule meetings and record minutes for multiple projects

• Prepare and distribute communications and correspondence such as memos, emails, reports, meeting agendas

• Support global case management in reconciliation activities

• Collaborate with internal teams to prepare for Regulatory Authority inspections and in relevant internal/external audits. Be an active contributor during audits and inspections by preparing and reviewing responses

• Participate in the development and maintenance of PV System policies, SOPs, work instructions, forms, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices

• Assist in safety database validation by performing user acceptance testing

• Escalate issues to management as needed

• Assist with individual projects assigned by global PV management in support of Clinical Safety and Pharmacovigilance departmental initiatives

• Provide assistance for the development, maintenance, and delivery of training materials for internal and external groups, as needed

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

• Bachelor’s degree preferably in life science, nursing, pharmacy, or other healthcare related profession

• Minimum of 2-3 years of direct pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization

• Experience with safety databases (ARGUS, ARISg, or other safety database applications), electronic data capture (EDC) systems, and electronic document management systems

• Knowledge of GCPs, ICH guidelines and FDA, EMA, MHRA, PMDA, and Health Canada and other international regulations and guidelines

• Working knowledge of MedDRA and WHO Drug dictionaries

• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment

• Detail-oriented, with good organizational, prioritization of competing requests/projects, and time management proficiencies. Must be able to work on multiple projects simultaneously and independently

• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures

• Proficient in standard computer software (Word, Excel, and Power point presentations)

• Outstanding communication skills (verbal and written) 

• Ability to manage multiple projects in a fast-paced environment 

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment

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