Associate Director / Director, Safety Conventions & Quality Standards

Associate Director / Director, Safety Conventions & Quality Standards Fully Remote | $185,000-$250,000 Our client is hiring a pharmacovigilance quality leader to take full ownership of safety conventions, quality standards, and continuous improvement across Patient Safety Operations. This is not a support function. The person in this seat defines and enforces the convention framework, designs QC strategy, converts error trends into measurable process gains, and owns the procedural document suite end-to-end. You'd partner cross-functionally with Regulatory Affairs, Clinical Operations, Quality Assurance, IT, and external vendors to drive consistency across a complex global PV environment. What you'd own: Case processing conventions across clinical and post-marketing safety operations QC framework design — scope, frequency, sampling methodology, risk-based prioritization Prospective and retrospective ICSR quality reviews for compliance and consistency Error trend analysis with root cause identification and targeted intervention Training programs tied to conventions, quality standards, and procedural updates Full suite of SOPs, work instructions, job aids, and convention guides CAPA management for convention deviations and quality events What the client is looking for: 10+ years in drug safety / pharmacovigilance with strong ICSR quality, conventions, or standards focus Deep command of global PV regulations:

ICH E2B, FDA, EMA, MHRA

Proven training development and delivery in a PV setting Argus experience required CAPA and quality event management experience Veeva, eTMF, and EDC exposure preferred

Compensation:

Associate Director:

$185,000-$221,000

Director:

$220,000-$250,000