Solid Biosciences · 1 day ago
Pharmacovigilance Operations Assoc Director
Charlestown, MA, US
Full-time
Hybrid
Lead/Staff, Director/Executive
$200K/yr - $230K/yr
3+ years expSolid Biosciences is a precision genetic medicine company focused on advancing gene therapy candidates targeting rare diseases. The Pharmacovigilance Operations Associate Director will support and execute global pharmacovigilance operational activities, ensuring compliance and timely safety operations in support of the company's growing pipeline.
BiotechnologyGeneticsHealth CareMedical
Responsibilities
Execute global pharmacovigilance operational activities for Solid’s clinical-stage gene therapy programs under the direction of PV leadership
Oversee day-to-day PV operations, including:
Case processing oversight for SAEs and AESIs
Compliance monitoring for expedited safety reporting (SUSARs) to global health authorities
Operational support for periodic safety reports (DSURs, IND Annual Reports, 6-month line listings)
Serve as the primary operational contact for outsourced PV vendors, supporting:
Day-to-day vendor oversight and issue resolution
Oversight of PV-related SOWs, Safety Management Plans
Monitoring of vendor performance against defined KPIs and SOWs
Support the migration of safety cases to a new safety database, including coordination with vendors, support of data reconciliation activities, and documentation review under established plans
Support the development, maintenance, and implementation of PV SOPs, work instructions, and operational processes
Partner with Clinical Operations, Clinical Development, Regulatory Affairs, Quality, and Biometrics to ensure accurate and timely safety data flow
Provide operational support for safety governance activities, including:
Safety Management Committees (SMCs)
DSMB/DMC interactions, as applicable
Support inspection and audit readiness activities, including document preparation, response drafting, and participation in mock inspections
Assist in tracking and implementing updates related to evolving global PV regulations and guidance
Provide day-to-day guidance and oversight to other PV staff or contractors, as applicable
Qualification
Required
Bachelor's degree in a life science or healthcare-related field
Minimum of 3–5 years of pharmacovigilance experience, with hands-on experience managing clinical-stage PV operations, preferably within rare disease and/or gene therapy programs
Strong working knowledge of global PV regulations and guidance, including FDA (21 CFR 312, IND safety reporting), EMA (GVP Modules), and ICH guidelines (E2A–E2F)
Demonstrated experience overseeing PV vendors and outsourced models
Experience supporting regulatory inspections and audits
Strategic and operational mindset with the ability to 'roll up sleeves' in a fast-paced biotech environment
Strong attention to detail with a high level of accountability and ownership
Excellent cross-functional communication and collaboration skills
Ability to interpret and operationalize regulatory guidance into practical, compliant processes
Comfort operating in ambiguity and contributing to the build-out of new systems and processes
Patient-focused perspective with an appreciation for the unique safety considerations of gene therapy and rare diseases
Proven ability to prioritize, manage competing deadlines, and influence without authority
Preferred
Advanced degree (PharmD, MPH, RN)
Experience supporting Phase 3 clinical trials, including blinded study designs and management of safety operations in compliance with blinding and unblinding procedures
Familiarity with safety databases (e.g., Argus, ArisG) and EDC-to-safety data reconciliation processes
Benefits
Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
401(k) program participation with competitive company matched contributions
Eligibility to participate in Solid’s Employee Stock Purchase Plan
Mobile phone subsidy for eligible employees
Tuition Reimbursement
Vision Coverage
Life Insurance
Voluntary Pet Insurance
Employee Discount Program on Travel, Entertainment, and Services
Daily Subsidized Lunch Delivery (onsite @ Hood Park)
Free Onsite Full-Service Gym (onsite @ Hood Park)
Employee Parking (onsite @ Hood Park)
Company
Solid Biosciences
Solid Biosciences is a life science company that conducts research for the treatment of Duchenne muscular dystrophy.
51-200 employees
H1B Sponsorship
Solid Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (3)
2023 (2)
2022 (4)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$810.3MKey Investors
Ultragenyx PharmaceuticalPerceptive AdvisorsJP Morgan
2025-02-18Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $109M
2022-09-30Post Ipo Equity· $75M
Leadership Team
Alexander Cumbo
CEO and President
Kevin Tan
Chief Financial Officer
Recent News
2026-01-13
2026-01-13
Company data provided by crunchbase