Pharmacovigilance Regulatory Reporting
hace 1 semana
**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
- Languages: Advanced level of **English**
- **2-**3**years of experience in pharmacovigilance activities (mandatory) Specifically in regulatory reporting, will be highly valued.
- 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
Could be located in any Mexico city.
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