Safety Systems Specialist

PrimeVigilance Ltd.; Pune District; Presencial; INR 900.000 - 1.200.000; Jornada completa

Descripción de la vacante

PrimeVigilance Ltd. seeks a Safety Systems Specialist to manage pharmacovigilance systems, primarily Argus Safety, including configuration, validation and data migrations. You will work with OAS and Axway integrations, optimize database performance and support reporting needs.

Responsibilities include leading client deployments, validating master tenants, and coordinating upgrades with IT and vendors. Strong SQL/PL/ PV process translation skills are essential.

Formación

• Bachelor's degree in IT or related field.
• ,

Responsabilidades

• Serve as SME for pharmacovigilance systems (Argus 8.x Oracle Cloud) and integrations (OAS, Axway).
• Lead project kick-off for client enterprise creation, validation and configuration.
• Support Argus MASTER tenant configuration/validation for client deployments.
• Identify database requirements and optimize performance for end users.
• Assist with safety system upgrades/patches, testing and implementation.
• Support data transfers and migrations using SQL development skills.
• Develop, validate and implement standard and custom reports.
• Coordinate with vendors to resolve system issues.
• Draft work instructions and SOPs for pharmacovigilance systems.
• Mentor staff and conduct user trainings on the safety database.

Conocimientos

SQL

PL/SQL

Pharmacovigilance

Project management

Communication

Global regulatory compliance

Educación

Bachelor's degree in Information Technology or related field

Herramientas

Oracle Argus Safety

OAS

Axway

Oracle Cloud

Descripción del empleo

Company Description

Medicine moves forward here. So will you.

At PrimeVigilance, patient safety is not one part of the job. It is why we exist.

We are a global pharmacovigilance specialist. Our teams help clients navigate complex regulations while keeping patient safety at the center of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that matters early and turning it into insight our clients can act on.

That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, North America, South America, Asia and Australia, we work in an environment built on kindness, flexibility, growth and belonging, where colleagues support one another and good ideas are heard wherever they come from.

If you want a role with real purpose, global reach and the chance to keep growing while you help protect patients, you will feel at home here. We would love to hear from you.

Job Description

The Safety Systems Specialist will work as part of the Safety & MI Systems team and will be responsible for database related activities including configuration management, issue resolutions, data migrations requiring strong SQL developer skills, for providing technical expertise on pharmacovigilance systems, specifically the Argus Safety database, including planning and validation. The role is critical to pharmacovigilance to support and maintain the overall safety system, electronic reporting to health authorities and ensuring compliance to the relevant regulatory requirements, policies and standards.

• Serves as subject matter expert for pharmacovigilance systems (Argus 8.x Oracle Cloud) and associated application integrations (eg OAS, Axway)
• Lead project kick-off for client enterprise creation, validation and configuration. Gather functional and technical requirements. Provide configuration solutions to support client case processing and reporting.
• Support configuration/validation of the Argus MASTER tenant enterprise used for client enterprise creation.
• Proactively identifies database requirements to maximize efficiency and quality of end user performance; takes initiative to investigate, develop and implement solutions. Proactively presents solutions to management.
• Support safety database and associated systems upgrades/patches for the IT team, including project planning, testing and implementation.
• Support client data transfers (data imports and exports), SQL developer skills required, including prior experience in data migrations.
• Support development, validation and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required.
• Manage and elevate system issues with the pharmacovigilance software vendors as needed.
• Assist with authoring pharmacovigilance system work instructions, standard operating procedures and associated forms.
• Maintains professional and technical knowledge through continuing education, such as workshops, reviewing professional publications, participating in professional organizations
• Accept project assignments as delegated by senior staff, as needed.
• Develops staff knowledge of the safety database through individual mentoring, classroom trainings, user workshops as needed
• Ensure compliance with relevant company policies and procedures.

Qualifications

• Bachelor's degree in Information Technology or related experience
• Demonstrated knowledge and experience with pharmacovigilance systems in a pharmaceutical company, biotech or CRO (on premise or cloud-based solution).
• Demonstrated knowledge and experience supporting Oracle Argus Safety system and application integrations (eg OAS, Axway)
• Demonstrated understanding of pharmacovigilance processes, ability to translate into technical solutions and implement within the pharmacovigilance system.
• Proficient in SQL and/or PL/SQL skills
• System technical subject matter expert for internal and external end users/clients.
• Excellent people and project management skills required.
• Experience with system validation and compliance with global regulations
• Excellent prioritization skills, strong analytical/problem solving skills and ability to multi-task preferred.
• Excellent oral skills, written communication skills and commitment preferred.
• Ability to work within a global Safety and MI team

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.

Department: Safety & Medical Information Systems

Requirements: