Pharmacovigilance Regulatory Reporting Specialist

IQVIA LLC; São Paulo; Híbrido; BRL 70 000 - 110 000; Tempo integral

Resumo da oferta

IQVIA LLC is seeking a Pharmacovigilance Regulatory Reporting Specialist for a 100% remote role based in São Paulo, Brazil. You will review safety data, prepare regulatory reports, and ensure compliance with SOPs while collaborating with the operations team.

Ideal candidates hold a life sciences degree, 2–3 years of PV regulatory reporting experience, strong English skills, and Argus proficiency. You will work independently and with cross-functional teams to support safety submissions and data

Qualificações

• Bachelor's degree in life sciences.
• 2–3 years of pharmacovigilance experience with regulatory reporting.
• Argus experience is required.
• Strong knowledge of medical terminology and safety databases.

Responsabilidades

• Process safety data according to applicable regulations and SOPs.
• Ensure quality, productivity, and timely delivery of reports.
• Track and manage cases per project plan.
• Identify quality problems and escalate to senior team members.
• Liaise with health care professionals and team members to resolve issues.
• Attend project meetings and provide feedback to operations managers.

Conhecimentos

Advanced English

Attention to detail

Independent worker

Organization skills

Formação académica

Bachelor's degree in life sciences

Ferramentas

Argus

Descrição da oferta de emprego

## Pharmacovigilance Regulatory Reporting SpecialistApply: São Paulo, Brazil: Full time: Posted 3 Days Ago: R1566710Job OverviewAs 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-basedIQVIA 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.comIQVIA 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.