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Safety Systems Specialist

Safety Systems Specialist

Primevigilance

3 - 6 years

6 - 9 Lacs

Pune

Posted:2 days ago| Platform:

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Skills Required

CRO Analytical Pharma Database Project planning Pharmacovigilance Oracle Information technology Reporting tools SQL

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Safety Database Specialist will work as part of the PV Client Success and Safety Systems IT Team and will be responsible database related activities including 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 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 8.x Oracle Cloud) and associated application integrations (eg OAS, Axway)
Lead client data transfers (data imports and exports), SQL developer skills required, including prior experience in data migrations.
Lead development, validation and implementation of standard and custom reports within company reporting tools. Query database to support inspections as required.
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.
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.

Bachelors 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).
Demonst

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Primevigilance

Pharmaceutical Services

Chicago

51-200 Employees

14 Jobs

Key People

Samir K. Khosla

Chief Executive Officer
Santiago Martínez

Chief Operating Officer
Luciana Bonifacio

Director of Business Development

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Safety Systems Specialist