Job#: 3015211 Job Description: 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.
Key Responsibilities
- 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.
Requirements
- 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 Google Cloud Platform/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.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
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