Safety Systems Specialist

Ergomed; Maharashtra; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Ergomed is seeking a Safety Systems Specialist to maintain and optimize pharmacovigilance systems, especially Argus Safety, across global deployments. You will configure, validate and support master tenant environments, coordinate data transfers and reporting, and work with vendors to resolve issues.

You will join a global Safety & MI team, contribute to SOPs, and advance state-of-the-art pharmacovigilance solutions while ensuring regulatory compliance.

Qualifications

• Bachelor's degree in Information Technology or related experience.
• Demonstrated knowledge and experience with pharmacovigilance systems.
• Experience supporting Oracle Argus Safety and integrations (OAS, Axway).
• Understanding of pharmacovigilance processes and translating to technical solutions.
• Proficient in SQL/PLSQL.
• Subject matter expert for end users/clients.
• Excellent people and project management skills.

Responsibilities

• Serve as SME for pharmacovigilance systems (Argus 8.x Oracle Cloud) and integrations (OAS, Axway).
• Lead project kick-offs for client enterprise creation, validation and configuration.
• Support configuration/validation of Argus MASTER tenant for client deployments.
• Identify database requirements and propose solutions to improve performance.
• Assist with safety database upgrades, testing and implementation.
• Support data transfers including migrations with SQL skills.
• Develop, validate and implement standard and custom reports; query data as needed.
• Manage system issues with vendors and escalate when required.
• Contribute to work instructions and SOPs for pharmacovigilance systems.
• Maintain knowledge through continuing education and training.

Skills

SQL

PL/SQL

Argus Safety

Oracle Cloud

OAS

Axway

Pharmacovigilance systems

Project management

Data migrations

Reporting tools

Education

Bachelor's degree in Information Technology

Tools

Oracle Argus Safety

OAS

Axway

Job 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.

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 escalate 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.

• 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

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.