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.
Key Responsibilities
- 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
Qualifications
- 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
Seniority Level
- Mid-Senior level
Employment Type
- Contract
Job Function
- Science and Research
Industries
- Staffing and Recruiting
- Pharmaceutical Manufacturing
- Biotechnology Research
Benefits
- Medical insurance
- Vision insurance
- 401(k)
Location & Salary
Somerville, MA — $95,000.00-$125,000.00
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