Pharmacovigilance Regulatory Reporting Specialist
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.
Previous experience working with Argus is required
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
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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.
Previous experience working with Argus is required
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
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.