Global PV Product Complaint Oversight Lead (Hybrid)

Scorpion Therapeutics; Chapel Hill (NC); Hybrid; USD 170,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Durham, NC seeks an Associate Director to lead the Global PV Product Complaint Management & Oversight, spanning devices, drugs, biologics, and combination products. This role governs end-to-end case processing and drives global procedures while ensuring adherence to EU MDR, IMDRF, 21 CFR, and ISO standards across lifecycle stages.

You will guide audits, CAPAs, and safety governance, managing cross-functional teams and vendor relationships to sustain continuous

Qualifications

• Bachelor's or higher degree in a relevant field.
• 7+ years' pharmacovigilance or product complaint experience supporting devices, biologics, or combination products.
• Experience with vendor oversight, post-marketing drug exposure, and safety databases (preferably Argus).

Responsibilities

• Oversee complaint handling processes.
• Develop and implement global procedures.
• Ensure compliance with international regulations (EU MDR, IMDRF, 21 CFR, ISO standards).
• Lead inspection readiness.
• Foster continuous improvement in safety governance.
• Manage cross-functional teams and vendor relationships.
• Provide training.
• Lead audits and CAPAs.

Skills

GMP/GDP knowledge

ISO standards

Global regulatory requirements

End-to-end case processing

Vendor management

Inspection readiness

Education

Bachelor's degree in a relevant field

Master's degree or PharmD

Tools

Argus

Job description

Scorpion Therapeutics in Durham, NC seeks an Associate Director to lead the Global PV Product Complaint Management & Oversight, spanning devices, drugs, biologics, and combination products. This role governs end-to-end case processing and drives global procedures while ensuring adherence to EU MDR, IMDRF, 21 CFR, and ISO standards across lifecycle stages.

You will guide audits, CAPAs, and safety governance, managing cross-functional teams and vendor relationships to sustain continuous