Safety Systems Specialist
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Safety Systems Specialist maintaining Argus pharmacovigilance databases for PrimeVigilance. Supporting SQL migrations, validation, reporting, integrations, and regulatory compliance.
Responsibilities:
- Perform database-related activities, including configuration management, issue resolution, and data migrations
- Provide technical expertise on pharmacovigilance systems, particularly Argus Safety
- Plan and support system validation
- Support and maintain the overall safety system and electronic reporting to health authorities
- Serve as subject matter expert for Argus 8.x Oracle Cloud and integrations such as OAS and Axway
- Lead project kick-offs for client enterprise creation, validation, and configuration
- Gather functional and technical requirements
- Provide configuration solutions for client case processing and reporting
- Support configuration and validation of the Argus MASTER tenant
- Identify database requirements and develop and implement efficiency and quality solutions
- Present solutions to management
- Support safety database and associated system upgrades and patches, including planning, testing, and implementation
- Support client data transfers, imports, exports, and data migrations
- Develop, validate, and implement standard and custom reports
- Query databases to support inspections
- Manage and escalate system issues with pharmacovigilance software vendors
- Author system work instructions, standard operating procedures, and associated forms
- Maintain professional and technical knowledge through continuing education
- Accept project assignments delegated by senior staff
- Develop staff knowledge through mentoring, classroom training, and user workshops
- Ensure compliance with company policies and procedures
Requirements:
- Bachelor's degree in Information Technology or related experience
- Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech, or CRO
- Demonstrated knowledge and experience supporting Oracle Argus Safety system and application integrations such as OAS and Axway
- Understanding of pharmacovigilance processes and ability to translate them into technical solutions
- Proficient in SQL and/or PL/SQL
- Experience with system validation and compliance with global regulations
- Excellent people and project management skills
- Excellent prioritization, analytical, problem-solving, multitasking, oral, and written communication skills
- Ability to work within a global Safety and MI team
Benefits:
- Remote work option
- Continuing education through workshops, reviewing professional publications, and participating in professional organizations
- Individual mentoring, classroom trainings, and user workshops
- Collaborative and supportive global team environment
- Growth and professional development opportunities
- Belonging-focused workplace culture
- Passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting
Similar Jobs
Hazardous Device Specialist / Public Safety Professional
Hazardous-device and public-safety professionals red-teaming Mercor’s frontier AI models. Writing dual-use prompts, evaluating responses, and documenting technically grounded reference answers.
Fire Safety Specialist
Référent sécurité pilotant la prévention incendie dans les parkings d’EFFIA, acteur majeur du stationnement urbain en France et Belgique. Coordonnant conformité, contrôles et plans d’action.
Occupational Health and Safety Specialist (SiFa)
Fachkraft für Arbeitssicherheit bei kaer, einem Anbieter für Arbeitsmedizin und Gesundheitsmanagement. Digitale Sicherheitsprozesse entwickeln, Kunden beraten und deutschlandweit vor Ort unterstützen.
Hazardous Device Specialist / Public Safety Professional
Hazardous-device experts red-teaming Mercor’s frontier AI models. Writing dual-use prompts, evaluating safety responses, and documenting technically grounded reference answers.
Senior Safety Reporting Specialist
Senior safety reporting specialist overseeing compliant pharmacovigilance reports at Thermo Fisher Scientific. Leading safety-reporting projects and mentoring colleagues to protect patient health.
Senior Safety Reporting Specialist
Senior Safety Reporting Specialist leading compliant pharmacovigilance reporting for Thermo Fisher Scientific. Overseeing complex submissions, regulatory timelines, process improvements, and team mentoring.
Corporate Safety Specialist – Rail
Corporate Safety Specialist providing hands-on safety leadership across Cando Rail & Terminals’ North American rail operations. Conducting site observations, risk assessments, incident investigations, and regulatory support.
Occupational Health and Safety Specialist (SiFa)
Fachkraft für Arbeitssicherheit bei kaer, einem Anbieter digitaler Gesundheits-, Arbeitsmedizin- und Sicherheitssysteme. Betreuung von Kunden in Deutschland mit 60 % Reisetätigkeit und flexibler Remote-Arbeit.
Occupational Safety Specialist (m/f/d)
Fachkraft für Arbeitssicherheit bei kaer, einem Anbieter medizinischer Vorsorge, Arbeitsmedizin und Arbeitssicherheit. Digitale Leistungen, Kundenbetreuung und 60 % deutschlandweite Reisetätigkeit.
Nuclear Safety Analysis Specialist
Nuclear safety specialist performing MCNP and SCALE analyses for reactor operations. Supporting BGS engineering and national-security clients with DOE-compliant safety documentation.
Digital Trust and Safety Specialist, Italian Speaking
Italian-speaking Digital Trust and Safety Specialist moderating social media content for Mercier Consultancy Group’s international staffing clients. Protecting users, enforcing policies, and reporting emerging digital threats.
TMF Specialist – Safety Processing, Min 2 Years Experience in Central File Management
TMF Specialist managing safety processing for clinical trials at Syneos Health. Requires 2+ years in central file management and relevant pharmaceutical experience.
Regional Field Safety Specialist – Europe
Regional Field Safety Specialist focusing on safety compliance in Germany and surrounding regions for a multinational tech company. Conducting audits, coaching, and managing safety programs throughout Europe.
Senior Drug Safety Specialist – Day Shift
Senior Safety Specialist performing Pharmacovigilance activities for a leading life sciences company. Joining a global team ensuring operational excellence in patient safety and compliance.
FSP Safety Reporting Specialist – Night Shift
Safety Reporting Specialist managing regulatory and safety reports for compliance with pharmacovigilance requirements. Ensuring accurate documentation and support for the global team in a fully remote role.
Biological Safety Specialist
Biological Safety Specialist ensuring compliance with medical device regulations. Developing safety documents and auditing biocompatibility results according to regulatory standards.
Safety & PV Specialist I
Safety & PV Specialist I process ICSR at Syneos Health, ensuring compliance with regulatory requirements and managing safety tracking systems.
No more related jobs available.