Operation Specialist 2
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Overview
The Operations Specialist 2 - Home Based Brazil is responsible for endtoend processing and oversight of Safety data applying indepth pharmacovigilance expertise and complex decisionmaking. This role acts as a subject matter specialist supports clinical trial and postmarketing activities leads or supports small to medium operational projects and mentors junior team members while ensuring compliance quality and timely delivery.
Key Responsibilities
- Perform fullservice processing of Safety cases (including SAEs) according to regulations SOPs and project requirements.
- Collect track assess and process Adverse Events (AEs) using safety databases including data entry coding narrative writing and case closure.
- Assess seriousness reportability causality listedness and expectedness; support medical review activities when required.
- Generate track and submit regulatory reports to health authorities and stakeholders within defined timelines.
- Support reconciliation activities literature screening quality reviews and adjudication processes.
- Coordinate translations and liaise with clinical teams investigators clients and internal functional groups.
- Ensure compliance with project protocols regulatory requirements and training obligations.
- Monitor project metrics productivity and quality indicators; provide feedback to management.
- Mentor and train junior team members; contribute to training initiatives and process improvements.
- Support Safety Publishing Risk Management Safety Surveillance and Medical Information activities as applicable.
- Participate in audits inspections working groups and continuous improvement initiatives.
Requirements
- Bachelors degree in Life Sciences Healthcare or related field.
- At least 3 years of Pharmacovigilance experience preferably including clinical trials and some postmarketing exposure.
- Be based in Brazil but work 100% remote.
- Strong experience with Safety databases (e.g. Argus Safety) including full data entry and narrative writing.
- Solid knowledge of global regional and local pharmacovigilance regulations and guidelines.
- Excellent attention to detail organizational skills and ability to manage multiple priorities under tight timelines.
- Strong communication skills (written and verbal) and ability to interact with crossfunctional teams and clients.
- Proven ability to work independently take ownership and collaborate effectively in a team environment.
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
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.
Required Experience:
IC
Key Skills
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
