A Data Officer job opportunity in India is available for candidates interested in pharmacovigilance, vigilance data management, drug safety, regulatory reporting, and quality compliance. The role focuses on accurate processing and tracking of safety data, database management, case processing, reporting, and support for regulatory activities.
Candidates with a bachelor’s degree in Life Sciences, Pharmacy, Nursing, Dentistry, or a related scientific discipline can apply. Experience in pharmacovigilance, drug safety, case processing, regulatory affairs, or database management is an advantage.
Data Officer Job Responsibilities
The selected candidate will support pharmacovigilance and vigilance operations across data management, case processing, reporting, and regulatory activities.
Vigilance Data Management
Key responsibilities include:
- Managing shared and client-specific mailboxes.
- Registering vigilance cases in internal tracking systems.
- Performing duplicate searches in safety databases.
- Conducting initial triage and data entry of vigilance cases.
- Coding medical information using MedDRA.
- Preparing and updating case narratives.
- Ensuring patient data is anonymized when required.
- Supporting follow-up requests and case closure activities.
- Assessing case seriousness and submission requirements.
- Supporting submissions to Competent Authorities, Ethics Committees, Partners, and Affiliates.
Database Management and Reporting
The Data Officer will also be responsible for:
- Generating reports and listings from safety databases.
- Performing database searches and data extraction.
- Supporting KPI calculations and activity monitoring.
- Preparing weekly, monthly, quarterly, and annual activity reports.
- Supporting reconciliation activities.
- Performing database quality checks.
Regulatory and Compliance Activities
The position includes exposure to several global pharmacovigilance and regulatory activities, including:
- Supporting EudraVigilance activities.
- Supporting ICSR downloads and submissions.
- Performing XEVMPD updates and submissions.
- Supporting reporting activities involving MHRA, FDA, and other Health Authorities where required.
- Maintaining compliance with applicable pharmacovigilance regulations and company procedures.
Quality and Process Improvement
Responsibilities may also include:
- Supporting implementation of new client projects.
- Participating in process optimization initiatives.
- Drafting and updating work instructions.
- Supporting technical agreements and operational procedures.
- Assisting with audits and inspections.
- Contributing to database quality and operational improvement activities.
Data Officer Eligibility Criteria
Candidates should have a Bachelor’s degree in one of the following fields:
- Pharmacy
- Life Sciences
- Nursing
- Dentistry
- Related scientific disciplines
Previous experience in Pharmacovigilance, Drug Safety, Case Processing, Regulatory Affairs, or Database Management will be an advantage.
Knowledge of pharmacovigilance regulations and safety databases is preferred.
Technical Skills Required
Candidates interested in this Data Officer pharmacovigilance job should ideally have knowledge of:
- Pharmacovigilance case processing
- MedDRA coding
- EudraVigilance
- Safety database management
- Database data entry
- Data reconciliation
- Microsoft Office
- KPI and activity reporting
- Regulatory compliance
Soft Skills
The role requires candidates who demonstrate:
- Strong attention to detail
- Excellent organizational skills
- Analytical and critical-thinking abilities
- Effective communication
- Ability to manage multiple priorities
- Ability to meet deadlines
- Team-oriented working style
Benefits and Career Opportunities
The position offers candidates an opportunity to gain exposure to:
- International Life Sciences operations
- Global pharmacovigilance activities
- Vigilance case management
- Safety databases
- EudraVigilance processes
- Regulatory reporting
- Quality and compliance activities
- Client project implementation
- Process improvement
- Audits and inspections
The role can be relevant to professionals looking to develop their careers in pharmacovigilance, drug safety, regulatory operations, and safety data management.
How to Apply
