GQR · 3 days ago
Director Drug Safety Operations
United States
Full-time
Remote
Senior Level, Lead/Staff
$200K/yr - $250K/yr
10+ years expGQR is supporting a well-established biotech company that is advancing innovative therapeutics. They are seeking an Associate Director/Director of Patient Safety Operations to oversee global safety operations across clinical development and post-marketing programs.
Big DataFinancial ServicesRecruitingRisk ManagementSearch Engine
Hiring Manager
Bryan Blair
Responsibilities
Lead day-to-day safety operations across clinical and post-marketing programs
Oversee case processing workflows, timelines, and quality across internal and external teams
Manage safety vendors/business partners to ensure compliance with KPIs and PV agreements
Drive third-party quality event management, CAPAs, and operational process improvements
Own SUSAR compliance oversight, tracking, and operational monitoring
Partner with IT and system providers to support safety systems (Argus), including data quality and validation
Support inspection readiness and participate in audit/inspection activities
Qualification
Required
10+ years in Drug Safety/Pharmacovigilance with strong operational leadership
Deep knowledge of global PV regulations (ICH, FDA, EMA, MHRA) and safety reporting requirements
Argus experience required (system and operational SME capability)
Strong vendor management experience (KPIs, compliance, escalation, CAPAs)
Excellent written/verbal communication and strong execution across global timelines
Life sciences degree or equivalent experience (HCP background acceptable; MD not required)
Preferred
Veeva, eTMF, EDC; audit/inspection involvement
Company
GQR
GQR redefines total talent solutions, offering a bespoke blend of staffing, search, advisory, managed services, and cutting-edge software tailored to every employer's unique needs.
201-500 employees
H1B Sponsorship
GQR 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 (2)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Steven Talbot
CEO
Hannah Roberts
President and Co-Founder of "Women @ GQR" Employee Resource Group
Recent News
2025-02-16
Company data provided by crunchbase