Pharmacovigilance Regulatory Reporting Specialist

IQVIA; São Paulo; Teletrabalho; BRL 60 000 - 100 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Regulatory Reporting Specialist to support safety data submission to regulatory authorities from a fully remote base. You will review, assess, and process safety information from multiple sources and distribute reports following SOPs and internal guidelines under senior team guidance.

Key duties include processing data per regulations, tracking cases per project plans, and liaising with healthcare professionals to resolve issues.

Qualificações

• Bachelor's degree in life sciences.
• Advanced level of English.
• 2–3 years of pharmacovigilance experience.
• Experience in regulatory reporting and Argus required.
• Strong medical terminology and safety database knowledge.

Responsabilidades

• Process safety data according to applicable regulations, 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 health care professionals to address project-related issues.
• Attend project team meetings and provide feedback to the operations manager.

Conhecimentos

Advanced English

Formação académica

Bachelor's degree in life sciences

Ferramentas

Argus

Descrição da oferta de emprego

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.