Regulatory Affairs Officer (UK Regulations)
Productlife Group · Ahmedabad · onsite · Posted 27d ago
Undisclosed2–8 yrsfulltimeSourced from
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About this role
Job Description
About the Role
We are looking for a detail-oriented and proactive Data Officer to support pharmacovigilance and vigilance data management activities. The successful candidate will ensure the accurate processing, tracking, and maintenance of safety data while supporting regulatory compliance and operational excellence.
The Data Officer plays a key role in managing vigilance cases, maintaining databases, generating reports, and supporting client and regulatory requirements.
Key Responsibilities Vigilance Data Management - Manage shared and client-specific mailboxes.
- Register vigilance cases in internal tracking systems.
- Perform duplicate searches in safety databases.
- Conduct initial triage and data entry of vigilance cases.
- Code medical information using MedDRA.
- Prepare and update case narratives.
- Ensure patient data anonymization when required.
- Support follow-up requests and case closure activities.
- Assess case seriousness and submission requirements.
- Submit cases to Competent Authorities, Ethics Committees, Partners, and Affiliates as applicable.
- Generate reports and listings from safety databases.
- Perform database searches and data extractions.
- Support KPI calculations and activity monitoring.
- Prepare weekly, monthly, quarterly, and annual activity reports.
- Contribute to reconciliation activities and database quality checks.
- Support EudraVigilance activities, including ICSR downloads and submissions.
- Perform XEVMPD updates and submissions.
- Support MHRA, FDA, and other Health Authority reporting activities where required.
- Participate in the implementation of new client projects.
- Contribute to process optimization initiatives.
- Draft and update work instructions, technical agreements, and operational procedures.
- Support audits and inspections when needed.
- Maintain compliance with applicable pharmacovigilance regulations and company procedures.
- Bachelor s degree in Life Sciences, Pharmacy, Nursing, Dentistry, or a related scientific field.
- Experience in Pharmacovigilance, Drug Safety, Case Processing, Regulatory Affairs, or Database Management is an advantage.
- Knowledge of pharmacovigilance regulations and safety databases is preferred.
- Pharmacovigilance case processing.
- MedDRA coding.
- EudraVigilance knowledge.
- Database management and data entry.
- Microsoft Office Suite.
- Reporting and KPI monitoring.
- Regulatory compliance awareness.
- Strong attention to detail.
- Excellent organizational skills.
- Critical thinking and analytical mindset.
- Effective communication skills.
- Team-oriented approach.
- Ability to manage multiple priorities and deadlines.
- Opportunity to work in an international Life Sciences environment.
- Exposure to global pharmacovigilance and regulatory activities.
- Professional development and career growth opportunities.
- Collaborative and dynamic working environment
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
pharmacovigilanceOperational ExcellenceProcess ImprovementPharmacycodingData ManagementanalyticalData EntryreconciliationLife Sciences