Associate Director, Drug Safety Operations Systems

Hybrid in Waltham, MA, US • Posted 30+ days ago • Updated 1 day ago

Contract W2

No Travel Required

Hybrid

$120 - $127/hr

Fitment

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Job Details

Skills

Collaboration
Communication
GVP
Management
Inspection
Conflict Resolution
Problem Solving
Project Management
Regulatory Affairs
Regulatory Compliance
pharmacovigilance
Argus

Summary

Duration: 6-month contract (extension & conversion possible)

Hours: 40/week

We are seeking an Associate Director, PV Systems to manage and enhance its global Argus Safety platform and PV reporting systems. This role will lead end-to-end safety systems activities including configuration, validation, E2B reporting, system integrations, and vendor collaboration. The position partners closely with PV Operations, Regulatory Affairs, Quality, and IT to ensure compliance with global GVP regulations and inspection readiness.

Requirements:

Expert-level experience with Argus Safety and RxLogix PV Reports
10+ years in pharmacovigilance safety systems and reporting
Strong knowledge of FDA/EMA/ICH E2B and GVP regulations
Proven experience with system validation, upgrades, and data migrations
Excellent communication, project leadership, and problem-solving 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.

Dice Id: 91099677
Position Id: 8839131
Posted 30+ days ago

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Associate Director, Drug Safety Operations Systems

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Job Details

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Summary

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