Safety Systems Specialist (homebased in India)
- Bengaluru, Karnataka, India
- Employees can work remotely
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance oﬀers holistic, top quality, cost-eﬀective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders and leaders have an unrivalled reputation in the sector with a network of expert associates across the world.
The Safety Database Specialist will work as part of the Safety System Administrator Team and will be responsible database administration activities, 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 adverse event reporting 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 7.x on premise and Argus 8.x Oracle Cloud) and associated application integrations (eg OBIEE, Argus Insight, Axway)
- 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.
- Manages the configuration/validation of the pharmacovigilance master tenant enterprise used for client enterprise creation.
- 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.
- Leads safety database and associated systems upgrades/patches for the IT team, including project planning, testing and implementation.
- Manage and escalate system issues with the pharmacovigilance software vendors as needed.
- Author, review and/or execute Validation test scripts in the implementation and testing of change controls.
- Lead client audits and regulatory inspections.
- Lead client data transfers (data imports and exports).
- Lead development, validation and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required.
- Lead for Argus Japan client setup, maintenance and data migrations.
- 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 OBIEE, Argus Insight, Axway)
- Expert level knowledge regarding configuration of drugs, devices, vaccines and combination products as per current global regulatory requirements.
- Knowledge of Oracle Argus Japan preferred.
- Demonstrated understanding of pharmacovigilance processes, ability to translate into technical solutions and implement within the pharmacovigilance system.
- Proficient SQL and/or PS/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 IT team
Why Should You Apply?
- You want be involved in a wide range of interesting projects and studies
- You'd like your achievements and hard work to be recognized
- You want to work for a growing company where there are opportunities for advancement
- You'd like to work in a company that has a great reputation with its clients and employees.
- Making a difference to people's lives matters to you