Associate Director, PSPV Compliance & Analytics (Remote)

Overview

Remote
Depends on Experience
Contract - W2
Contract - 6 Month(s)

Skills

pharmacovigilance
PV regulations
Argus

Job Details

We are seeking an Associate Director to lead compliance metrics, analytics, and investigations in support of global pharmacovigilance (PV) compliance. This role will focus on case processing, aggregate safety reporting, ICSR investigations, CAPA management, and inspection/audit readiness.

Responsibilities:

  • Manage compliance metrics for PV activities and generate periodic reports.

  • Investigate late ICSRs, conduct root cause analysis, and implement process improvements.

  • Oversee CAPA activities, ensuring timely completion.

  • Support PV inspections, audits, and vendor management.

  • Partner with global teams to maintain compliance with regulatory requirements.

  • Use Argus and other safety databases for data analysis and reporting.

Requirements:

  • Bachelor s degree in Life Sciences, Pharmacy, Nursing, or related field.

  • 5+ years of pharmacovigilance compliance experience.

  • Strong knowledge of PV regulations (ICH, FDA, EMA) and Google Cloud Platform standards.

  • Proficiency in safety databases (e.g., Argus) and Microsoft Excel.

  • Strong analytical, organizational, and communication skills.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.