Senior Safety Scientist

Role Summary

Senior Safety Scientist at Viridian Therapeutics. Responsible for ensuring the safety of clinical trial participants and the integrity of clinical trial data by monitoring, analyzing, and assessing adverse events and other safety data, identifying and validating safety signals, and supporting safety documentation and risk management across clinical development.

Responsibilities

• Safety Data Monitoring: Continuously monitor safety data from clinical trials to identify potential safety signals
• Safety Management Team: Organize meetings, summarize and analyze safety data and prepare meeting minutes
• Adverse 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 SUSARs
• Risk Management: Develop and implement risk management plans to mitigate potential safety risks
• Regulatory Compliance: Ensure compliance with all relevant regulatory guidelines, including FDA, EMA, and ICH guidelines
• Safety 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 Sheet
• Cross-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 participants
• Safety 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 operations
• Training and Education: Provide training and support to clinical trial staff on safety reporting and regulatory requirements

Qualifications

• Requires a Bachelor's degree in a scientific discipline (e.g., biology, pharmacy, nursing) with 10+ years of clinical safety or pharmacovigilance
• Advanced degree (e.g., Master's, PhD) preferred
• Strong understanding of clinical trial processes, regulatory requirements, and safety reporting guidelines
• 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/ArisG/Veeva Safety)
• Development and review of SOPs and Work Instructions
• 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
• Attention to detail and high level of accuracy
• Ability to work both independently and as part of a team
• Strong problem-solving skills and sound decision-making under pressure

Education

• Not specified beyond qualifications; advanced degree preferred

Additional Requirements

• Role based in Waltham, MA; office-based employees required to work in the office three days a week