Pharmacovigilance Operations Assoc Director

Solid Biosciences•Boston, MA

5h•Hybrid

About The Position

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich’s ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. We are seeking an Pharmacovigilance Operations Associate Director to support and execute global pharmacovigilance operational activities across Solid’s clinical development programs. This role will focus on day-to-day PV operations execution, vendor oversight, and cross-functional coordination. This position will play a key role in ensuring timely and compliant safety operations in support of Solid’s growing gene therapy pipeline This role will report to Sr. Director, Pharmacovigilance Sciences and will be based in Solid’s Corporate Headquarters located in Hood Park in Charlestown, MA or remote/ hybrid depending on candidate location and business needs.

Requirements

Bachelor’s degree in a life science or healthcare-related field is required; an advanced degree (PharmD, MPH, RN) is preferred.
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: 1. FDA (21 CFR 312, IND safety reporting) 2. EMA (GVP Modules) 3. ICH guidelines (E2A–E2F)
Demonstrated experience overseeing PV vendors and outsourced models.
Experience supporting regulatory inspections and audits.
Familiarity with safety databases (e.g., Argus, ArisG) and EDC-to-safety data reconciliation processes.

Nice To Haves

Experience supporting Phase 3 clinical trials, including blinded study designs and management of safety operations in compliance with blinding and unblinding procedures, is a plus

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: 1. Case processing oversight for SAEs and AESIs 2. Compliance monitoring for expedited safety reporting (SUSARs) to global health authorities 3. 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: 1. Day-to-day vendor oversight and issue resolution 2. Oversight of PV-related SOWs, Safety Management Plans 3. Monitoring of vendor performance against defined KPIs and SOWs 4. 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: 1. Safety Management Committees (SMCs) 2. 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

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)