Senior Manager, Pharmacovigilance Operations

At Viridian, 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.

Reporting to the Associate Director, PV Clinical Trials Operations, the Sr. Manager, PV Operations primarily serves as the PV Operations Functional Lead across Viridian clinical trials. This role is responsible for day-to-day execution of pharmacovigilance operational activities across assigned clinical trials and other PV activities, as needed.

Aligned with the broader PV Operations strategy and oversight framework, this role supports study teams, monitors compliance with applicable global safety reporting requirements and internal procedures, and oversees the day-to-day delivery of PV vendor and CRO services. The Sr. Manager partners closely with Clinical Operations, Data Management, PV Physicians, PV Scientists, Clinical Development, Regulatory Affairs, Quality Assurance, and external partners to support consistent operational execution, inspection readiness, and drive effective cross-functional collaboration.

This role may be based in Waltham, MA, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including, but not limited to):

• Own study-level PV operational planning and execution across assigned clinical trials, making decisions within established governance frameworks and ensuring deliverables, timelines, quality, and compliance expectations are met. Serve as the PV Operations Functional Lead on program and study teams, overseeing operational safety deliverables from study start-up through closeout
• Lead day-to-day clinical trial PV operational activities, including SAE, pregnancy, and other reportable safety event workflows, safety reporting readiness, study-level compliance monitoring, and related documentation in accordance with company SOPs, study plans, and Viridian requirements
• Lead implementation of study-level PV operational processes prior to study start, including safety database set-up, unblinding processes, safety reporting pathways, and study team/vendor training needs
• Direct day-to-day oversight of PV vendors and CROs, evaluate performance and compliance trends, and drive corrective actions and sustainable improvements when expectations are not met. Lead appropriate escalation and contribute to continuous process improvement initiatives
• Draft, review, and provide PV Operations input into study-level documents and tools, including Study Management Plans, Safety Management Plans, TMF Plans, SAE Reconciliation Plans, SAE and pregnancy report forms, data entry conventions, and safety-related EDC/eCRF guidance, consistent with cross-study standards and strategic direction.
• Partner cross-functionally with Clinical Operations, Data Management, PV Physicians, PV Scientists, Clinical Development, Regulatory Affairs, Quality Assurance, Medical Monitoring, Biometrics, and external vendors to lead the resolution of complex PV operational issues, monitor compliance, and escalate risks or trends to PV leadership and study governance forums, as appropriate
• Support ongoing PV inspection readiness activities, including clinical trial TMF completeness and quality checks, retrospective case reviews, inspection storyboard development, evidence gathering, and tracking identified gaps through resolution
• Other duties as assigned

• Bachelor’s degree in nursing, pharmacy, life sciences, healthcare, or a related scientific discipline preferred
• 8+ years of pharmacovigilance/drug safety experience, including significant experience in clinical trial safety operations; an equivalent combination of education and experience may be considered
• Demonstrated experience serving as a PV functional representative or operational lead for clinical trials, including study start-up, SAE processing oversight, safety reporting, SAE reconciliation, and safety database/EDC interface activities
• Strong working knowledge of global pharmacovigilance regulations and guidance relevant to clinical trials, including FDA, EMA, ICH/GCP, and safety reporting requirements
• Experience with PV vendor/CRO oversight, KPI/metric review, issue escalation, CAPA support, audit/inspection readiness, and documentation of sponsor oversight
• Experience developing or reviewing SOPs, Work Instructions, Safety Management Plans, SAE Reconciliation Plans, study-level plans, and safety agreement documents
• Knowledge of MedDRA and WHO Drug Dictionary terminology and experience with common safety database systems such as Argus, ArisG, Veeva Safety, or similar platforms
• Excellent organizational, analytical, problem-solving, written, and verbal communication skills, with the ability to present clearly to internal and external stakeholders
• Ability to work collaboratively in a fast-paced, cross-functional environment with changing priorities and multiple concurrent studies
• High integrity, sound judgment, accountability, and strong commitment to patient safety, inspection readiness, and ethical standards
• Proficient with Microsoft Office suite, including Word, PowerPoint, Excel, Outlook, SharePoint, and related collaboration tools
• Ability to travel up to 10-15%
• 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
• Competitive medical, dental, and vision coverage
• 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

Viridian 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.