Senior Manager, Pharmacovigilance Scientist

The Role:

ModernaTX, Inc. seeks a Sr. Manager, Pharmacovigilance Scientist for its Cambridge, Massachusetts location.

Here's What You'll Do:

• Provide therapeutic area Pharmacovigilance support and representation for developmental products in close collaboration with Medical, Clinical, Regulatory, Epidemiology, Data Management, and Biostatistics stakeholders.
• Partner with Pharmacovigilance physicians to provide Pharmacovigilance and clinical expertise and support for deliverables and activities related to signal management and drafting of responses to regulatory inquiries on product safety issues for assigned products, during all phases of the product life-cycle.
• Review safety sections and provide safety content for study protocols, statistical analysis plans, and other clinical study-related documents as well as standard design of tables, figures, and listings for safety data from clinical studies.
• Support data analytics for product submission activities for clinical trials including Investigator Brochures, Company Core information, and other Reference Safety information.
• Review clinical and post-marketing Safety data and scientific literature for safety information.
• Contribute to Safety contents for aggregate reports and Risk Management plans.

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

Minimum requirements:

• Requires a Master's degree, or foreign equivalent, in Pharmacology or related life science field and 6 years of experience as a Pharmacovigilance Scientist or related position providing pharmacovigilance support.
• 6 years of experience must include:
  
  • Adverse event analysis and signal detection;
  • Interpreting clinical data and assessing its relevance to drug safety;
  • Review of safety sections of clinical study-related documents, including study protocols, statistical analysis plan, and electronic Case Report Form (eCRF);
  • Preparation and submission of regulatory documents;
  • Preparation of aggregate reports including review of Periodic Benefit-Risk Evaluation Reports and safety summary reports; and
  • Utilizing clinical database Medidata Rave, and safety database ARGUS to conduct analysis and identify safety issues and signals.
  • This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.

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