DescriptionReporting 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 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
- Perform other duties, as assigned
Requirements- Requires a Bachelor's degree in a scientific discipline (e.g., biology, pharmacy, nursing) with 5+ 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
- The salary range for this position is commensurate with experience
Viridian 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 Viridian
