Safety Systems Specialist

Job not on LinkedIn

🔥 15 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Safety Specialist

👻 Ghost score 17%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• 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