Posted May 25, 2026 43 views
Eila Solutions seeks a dedicated and knowledgeable professional to join as a Regulatory Affairs and Pharmacovigilance Officer. This role focuses on ensuring all pharmaceutical products meet stringent regulatory compliance requirements while managing essential drug safety monitoring processes. The candidate will be instrumental in preparing, reviewing, and submitting regulatory documents aligned with local authority standards to secure timely product registrations, renewals, and variations. Emphasis is placed on maintaining adherence to regulatory guidelines and internal company policies.
In addition, this position oversees comprehensive pharmacovigilance activities, including adverse event reporting, safety data management, and maintaining up-to-date safety databases. The officer bridges communication between internal teams and regulatory authorities, facilitating approvals and effectively addressing queries. While this role does not require team management, it demands meticulous implementation of pharmacovigilance systems and standard operating procedures, along with conducting periodic reviews to ensure ongoing drug safety and risk management.
Responsibilities
- Prepare, review, and submit regulatory dossiers in accordance with local authority requirements to ensure compliance and product approval.
- Manage timely product registrations, renewals, and variations, maintaining adherence to regulatory timelines and guidelines.
- Monitor ongoing compliance with applicable regulatory guidelines and company policies to uphold quality and safety standards.
- Oversee pharmacovigilance activities, including accurate and prompt adverse event reporting and safety data handling to ensure patient safety.
- Maintain and regularly update safety databases with accurate information, ensuring proper documentation and traceability.
- Coordinate effectively with internal departments and regulatory bodies to facilitate approvals and address any queries or issues.
- Implement and uphold pharmacovigilance systems and standard operating procedures to maintain operational excellence.
- Conduct periodic safety data reviews and risk management activities to identify potential risks and recommend mitigations.
- Maintain comprehensive and accurate records of all regulatory submissions, approvals, and pharmacovigilance activities for audit and inspection readiness.
Skills
Eila Solutions
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