Senior Safety Database Specialist YD Talent Solutions

7.0 - 11.0 years

0 Lacs

chandigarh

On-site

The Senior Safety Database Specialist will be responsible for managing critical pharmacovigilance data workflows and ensuring regulatory compliance. The role involves working on advanced Safety Database platforms like Argus, ArisG, and SafetyEasy to configure and maintain the database with high data quality and accuracy. You will administer user roles, permissions, and access controls in compliance with data privacy and regulatory requirements. Additionally, the position requires coordinating and implementing system upgrades, patches, and hotfixes in collaboration with IT and vendor teams. Managing integration of safety databases with other systems, supporting periodic system validation, and ensuring compliance with global regulatory requirements are key aspects of the role. Providing end-user training and system support, participating in safety database migrations and data reconciliation projects, and maintaining documentation and audit trails are also essential responsibilities. The successful candidate will generate metrics and compliance dashboards related to case processing timelines, system performance, and data quality indicators. This individual will liaise with database vendors for issue resolution, enhancements, and service requests, as well as draft and maintain SOPs, work instructions, and user manuals related to safety database operations. Troubleshooting system issues, participating in validation activities, collaborating with cross-functional teams, and staying up-to-date on regulations are also important functions of the role. Qualifications and Experience: - Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field - 7-10 years of experience in Pharmacovigilance with expertise in Safety Databases - Hands-on experience with Oracle Argus Safety and/or other PV databases such as ArisG, SafetyEasy, VigiFlow, LSMV - Proficiency in MedDRA and WHO Drug Dictionary coding standards - Experience with case processing workflows, E2B compliance, and electronic submissions - Familiarity with SQL, XML, and data query tools for ad-hoc data retrieval and troubleshooting - Exposure to safety database upgrades, patch installations, and configuration management - Strong understanding of global PV regulations and guidelines - Experience in preparing for and supporting audits and inspections - Knowledge of GxP practices, validation principles, and system lifecycle documentation - Strong verbal and written communication skills for interaction with cross-functional teams - Strong documentation and SOP adherence skills The Senior Safety Database Specialist will play a crucial role in ensuring the integrity and compliance of pharmacovigilance data management processes within the organization.,

Posted 1 week ago

Apply

Senior Database Specialist YD Talent Solutions

7.0 - 11.0 years

0 Lacs

chandigarh

On-site

As a Senior Safety Database Specialist at our client's contract research organization in Chandigarh, India, you will be responsible for managing critical pharmacovigilance data workflows using platforms such as Argus, ArisG, and SafetyEasy to ensure regulatory compliance. Your role will involve configuring and maintaining the Safety Database with a focus on data quality and accuracy, administering user roles in compliance with regulatory requirements, and supporting global pharmacovigilance operations for various pharmaceutical clients. Your key responsibilities will include coordinating system upgrades, managing database integrations, supporting system validation activities, ensuring compliance with global regulatory standards, providing end-user training and support, and participating in data reconciliation projects during system transitions or audits. Additionally, you will be involved in maintaining documentation, generating compliance metrics, liaising with database vendors, drafting SOPs and user manuals, troubleshooting system issues, and collaborating with cross-functional teams to stay updated on regulations. To be successful in this role, you should have a Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field with at least 7-10 years of experience in Pharmacovigilance and expertise in Safety Databases. You should have hands-on experience with Oracle Argus Safety and/or other PV databases, familiarity with coding standards, proficiency in data query tools, exposure to system integration, and a strong understanding of global PV regulations and guidelines. Excellent communication skills, documentation abilities, and adherence to SOPs are also essential for this position.,

Posted 1 week ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.