Associate Director - Pharmacovigilance

Associate Director, Safety Systems

Seeking an experienced Associate Director, Safety Systems to support global pharmacovigilance operations during a period of growth. This role serves as the SME for Argus Safety and RxLogix PV Reports
, partnering cross-functionally to ensure compliant, efficient safety systems.

• Lead administration, configuration, validation, and enhancement of Argus Safety and PV Reports
• Manage user access, workflows, dictionaries, E2B gateways, and reporting rules
• Develop PV SOPs and technical documentation
• Generate aggregate, periodic, and ad hoc safety reports
• Support audits, inspections, CAPAs, and regulatory compliance
• Partner with PV Operations, Regulatory, Quality, IT, and vendors
• Support system upgrades, migrations, integrations, and business continuity planning

• 10+ years in PV Safety Systems
• Expert in Argus Safety and RxLogix PV Reports
• Strong knowledge of FDA, EMA, and ICH E2B/GVP regulations
• Experience with system validation, upgrades, and data migrations
• SQL/relational database experience preferred
• Strong communication and stakeholder management skills

• Mid-Senior level

• Contract

• Science and Research

• Staffing and Recruiting
• Pharmaceutical Manufacturing
• Biotechnology Research

• Medical insurance
• Vision insurance
• 401(k)

Somerville, MA — $95,000.00-$