Safety Scientist

DescriptionAt Viridian Therapeutics, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions. Reporting to the Director, Pharmacovigilance Sciences, the Safety Scientist is responsible for ensuring the safety of clinical trial participants and the integrity of clinical trial data. This role involves monitoring, analyzing, and assessing adverse events and other safety data from clinical trials and other sources, to identify and validate safety signals. The Safety Scientist collaborates primarily with the Product Safety Lead/Safety Physician for assigned products, and also with cross-functional team members to ensure active safety surveillance of SAEs and other clinical trial safety data and lead/assist in the preparation of safety-related documents. The Safety Scientist will support the Product Safety Lead to organize and prepare for the Quarterly Safety Management Team, and other safety review meetings, as well as prepare and archive the meeting minutes. They will work with other functional groups to develop and implement risk management strategies to mitigate identified and potential risks for clinical trial participants during clinical development.This role may be remote or based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week. For a remote role, travel to headquarters may be required at discretion of management. Responsibilities (including, but not limited to):Safety Data Monitoring: Continuously monitor safety data from clinical trials to identify potential safety signalsSafety Management Team: Organize meetings, summarize and analyze safety data and prepare meeting minutesAdverse Event Reporting: Ensure the timely collection, analysis, and reporting of adverse events in accordance with regulatory requirements and company policies. Track and monitor all SAEs and SUSARsRisk Management: Develop and implement risk management plans to mitigate potential safety risksRegulatory Compliance: Ensure compliance with all relevant regulatory guidelines, including FDA, EMA, and ICH guidelinesSafety Documentation: Prepare and review safety-related documents, including Safety Management Plan, Study Protocols and Amendments, Informed Consent Forms, Investigator Brochure, DSUR/PSUR, CTD Module 2.5 & 2.7.4, Risk Management Plan and Company Core Data SheetCross-Functional Collaboration: Work closely with clinical operations, clinical development, regulatory affairs, and other departments, including the PV vendor, to ensure the safety of clinical trial participantsSafety Signal Detection: Oversee the use of statistical methods and data analysis tools to detect and evaluate safety signals.Literature Surveillance: Oversee the PV vendor literature surveillance plan and operationsTraining and Education: Provide training and support to clinical trial staff on safety reporting and regulatory requirementsPerform other duties, as assignedRequirementsRequires a Bachelor's degree in a scientific discipline (e.g., biology, pharmacy, nursing) with 5+ years of clinical safety or pharmacovigilanceAdvanced degree (e.g., Master's, PhD) preferredStrong understanding of clinical trial processes, regulatory requirements, and safety reporting guidelinesThorough knowledge of relevant EU GVP, FDA and ICH guidelines, including Good Clinical Practices (GCP) guidelinesKnowledge of MedDRA and WHO Drug Dictionary terminology and its application as well as experience with common safety database systems (Argus/ArisG/Veeva Safety)Development and review of SOPs and Work InstructionsExcellent organizational skills and demonstrated ability to navigate in a fast-paced environment with changing prioritiesExcellent verbal and written communication skills including the ability to present to both internal and external partnersAttention to detail and high level of accuracyAbility to work both independently and as part of a teamStrong problem-solving skills and sound decision-making under pressureThe salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:· 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 ViridianViridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.Employee Type: FT Exempt