Pharmacovigilance Regulatory Reporting

Job Overview

As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities. Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members.

Essential Functions

1. Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
2. Ensure compliance with quality, productivity, and delivery standards per project requirements.
3. Track cases as applicable to the project plan.
4. Identify and report quality problems to senior team members.
5. Liaise with different functional team members and health care professionals to address project-related issues.
6. Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes.

Qualifications

1. Bachelor's degree in life sciences
2. Advanced level of English
3. Up to 3 years of experience in pharmacovigilance activities
4. Good knowledge of medical terminology and applicable safety databases.
5. Strong organizational skills, attention to detail, and ability to work independently and as part of a team.

Work modality: 100% home-based