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