Medical Director - Drug Safety & Pharmacovigilance

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Viridian Therapeutics, Inc.

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Description

• Lead core medical safety activities within the PV organization to support the monitoring and evaluation of the safety profile of assigned products. • Provide medical and scientific expertise in all aspects of Drug Safety and Pharmacovigilance. • Lead preparation for and running of quarterly Safety Management Team meetings. • Assist in implementing the overall clinical strategy for lead programs. • Design and implement safety strategy for clinical studies. • Assist in clinical data review, analysis, and interpretation. • Coordinate safety outputs from the clinical and safety database. • Collaborate with appropriate clinical, medical, quality, and regulatory counterparts. • Review SAEs and SUSARs, assure outputs from the safety database. • Assist in covering the needs of medical affairs by helping lead the continued development and execution of a Medical Affairs strategy.

Requirements

• Medical Doctor Degree required. • 7+ years of pharmacovigilance/related experience, including experience in aggregate safety reports, safety signal management/detection activities, critical review of safety data, case processing of SAEs, and preparing other regulatory documents. • Knowledge of Aggregate Report requirements and experience in the creation of DSURs, PSURs, NDA Periodic Reports, and IND Annual Reports. • Demonstrated knowledge of relevant FDA, EMA, International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing both Safety reporting and processing for clinical trial environments. • Thorough knowledge of relevant EU GVP, FDA and ICH guidelines, including Good Clinical Practices (GCP) guidelines. • Knowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus). • Working knowledge of Risk Management requirements and activities. • Thorough understanding of the drug development process and context applicable to safety surveillance activities. • Development and review of SOPs and Work Instructions. • Vendor Management oversight responsibilities • Participation in clinical study team meetings and activities. • Excellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing priorities. • Excellent verbal and written communication skills including the ability to present to both internal and external partners. • Hands-on style with proven ability to work in an entrepreneurial environment and ability to manage and outsource work as required. • Strong commitment to ethical standards • Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) • Approximately 10-15% travel may be required.

Benefits

• Competitive pay and stock options for all employees • Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents • Fertility and mental health programs • Short- and long-term disability coverage • Life, Travel and AD&D • 401(k) Company Match with immediate company vest • Employee Stock Purchase plan • Generous vacation plan and paid company holiday shutdowns • Various mental, financial, and proactive physical health programs covered by Viridian