Senior Safety Database Specialist

Job Description

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 :

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 :

Requirements

Oracle Argus Safety, PV databases, ArisG, SafetyEasy, VigiFlow, LSMV, MedDRA, Regulatory Compliance, Safety Systems, Configuration, Implementation, Pharmacovigilance