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
Up to 2-3 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
Could be located in any Mexico city.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
At IQVIA, we are seeking a dedicated and detail-oriented Regulatory Reporting Specialist for Pharmacovigilance to join our vibrant team in Mexico City. In this role, you will play a crucial part in ensuring the safety of medications by submitting essential safety reports to regulatory authorities. Your responsibilities will include reviewing, assessing, and processing safety data from various sources, all while adhering to regulations, Standard Operating Procedures (SOPs), and internal guidelines. You'll work closely with senior operation team members who will provide guidance and support as you navigate your tasks. A significant part of your daily routine will involve liaising with different team members and healthcare professionals to tackle project-related issues while attending project meetings where your feedback will help shape operations. With a bachelor’s degree in life sciences and a passion for safety and compliance, coupled with 2-3 years of pharmacovigilance experience, you will thrive in our collaborative and supportive work culture. This position is 100% home-based, allowing you flexibility while you engage in meaningful work that helps improve patient outcomes. If you're ready to integrate your knowledge of medical terminology and databases, alongside strong organizational skills, to contribute to our mission at IQVIA, we would love to hear from you!
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