Pharmacovigilance Regulatory Reporting (Trilingual)

IQVIA; United States; Teletrabalho; USD 90 000 - 120 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Regulatory Reporting Specialist to manage safety report submissions to regulatory authorities and coordinate data from diverse sources. This is a 100% home-based role in the United States with multilingual requirements.

Professionals should hold a life sciences degree, have at least 1 year in pharmacovigilance (regulatory reporting preferred), and be proficient with safety databases (Argus is desirable).

Qualificações

• Bachelor’s degree in life sciences required.
• Advanced level of English, Spanish and Portuguese.
• 1 year of pharmacovigilance experience, specifically in regulatory reporting.
• Experience with safety databases; Argus is desirable.

Responsabilidades

• Process safety/regulatory data per project requirements.
• Ensure compliance with quality, productivity, and delivery standards.
• Track cases per project plan.
• Identify and report quality problems to seniors.
• Liaise with cross-functional teams and healthcare professionals.
• Attend team meetings and provide feedback to operations.

Conhecimentos

English

Spanish

Portuguese

Pharmacovigilance experience

Regulatory reporting

Argus

Formação académica

Bachelor’s degree in life sciences

Ferramentas

Argus

Descrição da oferta de emprego

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. This is a trilingual role requiring fluency in English, Spanish, and Portuguese.

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, Spanish and Portuguese.
• 1 year of experience in pharmacovigilance activities (mandatory) Specifically in regulatory reporting, will be highly valued.
• Previous experience working with Argus is desirable.
• 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.