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 11).
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.
Oracle Argus Safety, PV databases, ArisG, SafetyEasy, VigiFlow, LSMV, MedDRA, Regulatory Compliance, Safety Systems, Configuration, Implementation, Pharmacovigilance
Education
Bachelors
Senior Safety Database Specialist
