Associate Director, Safety Systems

Our Waltham based pharmaceutical client is seeking an Associate Director, Safety Systems to manage and maintain a global Argus drug safety platform. This role will oversee end‑to‑end safety system activities including reporting, E2B transmissions, and system interfaces. The ideal candidate will combine deep pharmacovigilance expertise with strong technical knowledge of Argus and PV Reports, ensuring compliance, efficiency, and inspection readiness across global operations.

$110.00/hr - $125.00/hr

Direct message the job poster from Stratacuity:
Proven Scientific Placement

• Manage Safety Systems user access, configuration updates, testing, and documentation.
• Lead validation, process improvements, and system enhancements.
• Develop and maintain SOPs, work instructions, and PV documentation.
• Design queries/reports in PV Reports to support aggregate, periodic, and ad hoc reporting.
• Configure and maintain electronic gateways, E2B profiles, and troubleshoot transmission issues.
• Collaborate with PV Operations, Regulatory Affairs, and Quality Assurance to ensure compliance with global safety reporting guidelines.
• Support audits, inspections, and vendor oversight as a subject matter expert.
• Provide technical/data management support to ensure accuracy and consistency of safety data.
• Train junior staff and vendors on safety system responsibilities.
• Contribute to business continuity planning and corrective/preventive action initiatives.

• 10–12 years of relevant experience in Safety Systems;
  Bachelor’s or advanced degree in life sciences, nursing, pharmacy, or related healthcare field.
• Expert knowledge of Argus Safety and RxLogix PV Reports; experience with other PV systems (Aris Global, Veeva, etc.) preferred.
• Strong technical expertise with proven ability to lead projects and deliver results.
• Knowledge of relational databases, SQL, and data migrations.
• Solid understanding of GCP/GVP regulations (FDA, EMA, ICH E2B).
• Familiarity with PSMF documentation and audit readiness requirements.
• Excellent communication, influencing, and negotiation skills.
• Highly organized, detail‑oriented, and able to manage multiple projects under tight timelines.
• Prior experience with safety database configuration, validation, and upgrades strongly preferred.

• Mid-Senior level

• Contract

• Management

• Biotechnology Research and Pharmaceutical Manufacturing

• Medical insurance
• Vision insurance
• 401(k)

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