Senior Safety Database Specialist

Senior Safety Database Specialist - Chandigarh, India

Company Overview
Our Client is a contract research organization offering Pharmacovigilance, Regulatory, Evidence Evaluation and Technology Solutions, which are phase dependent. These verticals cover planning, launch and lifecycle management of Pharmaceutical, Consumer products and Medical devices. We are based out of Chandigarh and are currently hiring for our Regulatory affairs team.

Basic Function:
Our Client is seeking an experienced Safety Database Specialist like Argus, ArisG and SafetyEasy to manage critical pharmacovigilance data workflows and ensure regulatory compliance. You will work on advanced Safety Database platform configurations, manage case processing accuracy, and support global PV operations across different pharmaceutical clients.

Functional Responsibilities:

• Configure, maintain and manage the Safety Database with high data quality and accuracy.

• Administer user roles, permissions, and access controls in compliance with data privacy and regulatory requirements.

• Coordinate and implement system upgrades, patches, and hotfixes in collaboration with IT and vendor teams.

• Manage integration of safety databases with other systems such as E2B (R2/R3) gateways, signal detection tools, or document management systems.

• Support periodic system validation, including authoring/review of validation documents (URS, FRS, IQ/OQ/PQ).

• Ensure compliance with global regulatory requirements (e.g., EMA, FDA, PMDA) and standards such as 21 CFR Part 11 and EU Annex 11.

• Provide end-user training and system support to case processors, medical reviewers, and QA personnel.

• Participate in safety database migrations and data reconciliation projects during system transitions or audits.

Requirements Job Description:

• Maintain documentation and audit trails, and support internal/external audits and regulatory inspections.

• Generate metrics and compliance dashboards related to case processing timelines, system performance, and data quality indicators.

• Liaise with database vendors (e.g., Argus) for issue resolution, enhancements, and service requests.

• Draft and maintain SOPs, work instructions, and user manuals related to the safety database operations.

• Troubleshoot system issues and participate in validation activities.

• Collaborate with cross-functional teams and stay up-to-date on regulations.

Note:

The above statements describe the general nature and level of work being performed, and are not an exhaustive list of all responsibilities required for the position.

Qualifications and Experience:

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, or a related field.

• 7–10 Years in Pharmacovigilance with expertise in Safety Databases

• Hands-on experience with Oracle Argus Safety (latest versions) and/or other PV databases such as ArisG, SafetyEasy, VigiFlow, LSMV.

• Experience with case processing workflows, E2B (R2/R3) compliance, and electronic submissions.

• Proficiency in MedDRA and WHO Drug Dictionary coding standards.

• 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.

• Experience in system integration with document management systems, signal detection tools, or reporting platforms (e.g., Power BI, Spotfire).

• Strong understanding of global PV regulations and guidelines (ICH E2B, E2D, GVP Modules, 21 CFR Part 11, EU Annex

• Experience in preparing for and supporting audits and inspections.

• Knowledge of GxP practices, validation principles (CSV), and system lifecycle documentation (URS, FRS, IQ/OQ/PQ).

• Ability to identify and resolve database/system issues with root cause analysis.

• Good verbal and written communication skills to interact with cross-functional teams (PV, QA, IT, Vendors).

• Strong documentation and SOP adherence skills.

---