Remote Associate Director, Pharmacovigilance

Civica, Inc.; Lehi (UT); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Civica, Inc. is seeking a QA Associate Director, Pharmacovigilance to lead its pharmacovigilance program and complaint intake across its generic and biosimilar medicines, including combination products. You will ensure cGMP compliance, SOP adherence, and regulatory alignment.

This remote role requires strategic leadership, PV expertise, and oversight of third-party call centers, data entry, and regulatory submissions while driving continuous process improvements and safety decisions.

Qualifications

• Over ten years in the pharmaceutical industry, preferably PV/safety roles for marketed products.
• Experience establishing a PV program as Market Authorization Holder is a plus.
• Strong written and verbal communication; technical writing skills.

Responsibilities

• Lead Civica pharmacovigilance function and ensure regulatory compliance.
• Oversee third party call center intake, triage, and medical inquiries.
• Establish quality checks for AE case processing and regulatory submissions.
• Manage PV activities for new product introductions or discontinuations.
• Support safety signal evaluation, benefit-risk assessment, and regulatory inspections.
• Monitor metrics and report to Civica leadership.

Skills

Pharmacovigilance

Leadership

Regulatory compliance

Quality systems

Project management

Communication skills

GXP knowledge

Inspection readiness

Problem solving

Vendor management

Education

BSN

RN

PharmD

PA / DO / MD

Job description

Civica, Inc. is seeking a QA Associate Director, Pharmacovigilance to lead its pharmacovigilance program and complaint intake across its generic and biosimilar medicines, including combination products. You will ensure cGMP compliance, SOP adherence, and regulatory alignment.

This remote role requires strategic leadership, PV expertise, and oversight of third-party call centers, data entry, and regulatory submissions while driving continuous process improvements and safety decisions.