Associate Director - Pharmacovigilance

Talent Groups; Massachusetts; On-site; USD 95,000 - 125,000; Part time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A leading staffing and recruiting firm is seeking an experienced Associate Director, Safety Systems to support global pharmacovigilance operations. Key responsibilities include managing Argus Safety and PV Reports, performing system enhancements, and ensuring regulatory compliance. Must possess over 10 years of experience in pharmacovigilance and be an expert in Argus Safety and RxLogix PV Reports. This contract role is based in Somerville, MA, with a salary range of $95,000.00 to $125,000.00.

Qualifications

• 10+ years in Pharmacovigilance Safety Systems.
• Expert in Argus Safety and RxLogix PV Reports.
• Strong knowledge of FDA, EMA, and ICH E2B/GVP regulations.

Responsibilities

• Lead administration and enhancement of Argus Safety and PV Reports.
• Manage user access, workflows, and reporting rules.
• Generate periodic and ad hoc safety reports.

Skills

Argus Safety

RxLogix PV Reports

FDA regulations

EMA regulations

ICH E2B/GVP regulations

SQL/relational databases

Stakeholder management

Communication skills

Job description

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