Pharmacovigilance Regulatory Reporting
hace 5 días
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
- Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
- Ensure compliance with quality, productivity, and delivery standards per project requirements.
- Track cases as applicable to the project plan.
- Identify and report quality problems to senior team members.
- Liaise with different functional team members and health care professionals to address project-related issues.
- Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes.
Qualifications
- Bachelor's degree in life sciences
- Advanced level of English
- Up to 3 years of experience in pharmacovigilance activities
- Good knowledge of medical terminology and applicable safety databases.
- Strong organizational skills, attention to detail, and ability to work independently and as part of a team.
Work modality: 100% home-based
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