Safety Systems Specialist

This is a fully remote position, open to applicants in India.

📋 Description

• Execute database-related tasks, encompassing configuration management, issue resolution, and data migrations.

• Offer technical expertise on pharmacovigilance systems, specifically Argus Safety.

• Organize and assist in system validation processes.

• Maintain and support the overall safety system and electronic reporting to health authorities.

• Act as a 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 efforts.

• Collect functional and technical requirements.

• Provide configuration solutions for client case processing and reporting needs.

• Assist in the configuration and validation of the Argus MASTER tenant.

• Identify database requirements and devise and implement efficiency and quality solutions.

• Present solutions to management for consideration.

• Aid in safety database and related system upgrades and patches, including planning, testing, and implementation.

• Facilitate client data transfers, imports, exports, and data migrations.

• Develop, validate, and implement both standard and custom reports.

• Query databases to support inspections effectively.

• Manage and escalate system issues with pharmacovigilance software vendors as necessary.

• Draft system work instructions, standard operating procedures, and related forms.

• Maintain professional and technical knowledge through ongoing education.

• Accept project assignments as delegated by senior staff members.

• Enhance staff knowledge through mentoring, classroom training, and user workshops.

• Ensure adherence to company policies and procedures.

⛳️ Requirements

• Bachelor's degree in Information Technology or equivalent experience.

• Proven knowledge and experience with pharmacovigilance systems in a pharmaceutical organization, biotech, or CRO.

• Demonstrated knowledge and experience in supporting the Oracle Argus Safety system and application integrations such as OAS and Axway.

• Understanding of pharmacovigilance processes with the capability to translate them into technical solutions.

• Proficient in SQL and/or PL/SQL programming languages.

• Experience in system validation and compliance with global regulations.

• Strong people and project management skills.

• Excellent prioritization, analytical, problem-solving, multitasking, and both oral and written communication skills.

• Ability to collaborate within a global Safety and MI team.

🏝️ Benefits

• Remote work option available.

• Opportunities for continuing education through workshops, reviewing professional publications, and participating in professional organizations.

• Individual mentoring, classroom training, and user workshops provided.

• Collaborative and supportive global team environment.

• Opportunities for growth and professional development.

• A workplace culture focused on belonging.

• A passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.