This role will require special working days as National Holidays and weekends.

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.1-2 years of experience in pharmacovigilance activities. Ideal profile will have specific experience in Regulatory Submissions.Good knowledge of medical terminology and applicable safety databases (ARGUS).Strong organizational skills, attention to detail, and ability to work independently and as part of a team.

Work modality:

100% home-basedWill require to work some National Holidays.Will require to work alternate weekends.

What we offer?

Private Medical InsuranceInternet allowanceEmployee Assistance Program: free and confidential support available 24/7 for you and your family such as counselling, referrals and work-life resources.GympassAdditional week of vacations100% work from home!

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