Director of Pharmacovigilance Operations

Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly.

This person will be responsible for establishing Moderna’s Pharmacovigilance Processes and Operations and will be accountable for their execution across the Moderna drug development ecosystem.

* Provide guidance for the development of global Medical Safety/Pharmacovigilance strategies. * Establish and maintain policies and procedures for the Medical Safety/Pharmacovigilance function. * Identify and evaluate safety signals through the assessment of single case safety reports and aggregate trend analyses. * Assure oversight for the medical review of safety events to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data. * Ensure the ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert, working in partnership with the Moderna Therapeutics’ ventures to bring potential safety issues to the attention of the clinical team and upper management. * Provide support for safety sections of clinical documents, including the review and approval of the safety portion of aggregate reports, protocols, final study reports, IB, and other documents, as needed. * Provide input and review of responses to regulatory agency questions with regard to patient safety.

**Qualifications** * RN, Pharm D or PhD and minimum 6-8 years Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization. * Working knowledge of relevant FDA, EU, ICH guidelines and regulations. * Experience working with CROs, vendors, and relationship management preferred. * Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding. * Familiarity with common Safety databases (e.g. ArisG, Argus) preferred. * Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way. * Outstanding communication skills (verbal and written). * Ability to manage multiple projects in a fast-paced environment. * Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment. **Competencies** * Effective Communication * Technical/Professional Knowledge * Independence/Teamwork * Initiating Action * Innovation