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 2 days ago

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