Senior Drug Safety Specialist
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Drug Safety Specialist / Senior Specialist Job Summary
We are looking for a Sr Drug Safety Specialist based in Brazil to work remote and support the triage and processing of Individual Case Safety Reports (ICSRs) from clinical trials and postmarketing sources ensuring timely and compliant submissions to global regulatory authorities.
Key Responsibilities
Process ICSRs including case validation dayzero determination review of source documents and escalation of special safety situations.
Perform medical coding narrative writing listedness assessments followup determination and Analysis of Similar Events.
Ensure workflow compliance by reviewing safety database timelines and case progression.
Conduct reconciliation between clinical trial databases and safety systems.
Execute due diligence activities including query distribution and followup with external reporters.
Contribute to compliance productivity and quality performance metrics.
Support continuous improvement initiatives and inspection readiness.
Make operational decisions aligned with SOPs work instructions and regulatory standards.
Required Knowledge & Experience
Understanding of global pharmacovigilance regulations (ICH GVP FDA EMA MHRA NMPA etc.).
Experience with safety databases and case processing (intake triage coding narratives due diligence).
Clinical knowledge of therapeutic areas and drug classes (preferred).
Strong timemanagement skills and attention to detail.
Ability to collaborate with Safety Operations Medical Review Clinical Operations Product Safety Leads and other stakeholders.
Education & Experience Requirements
Bachelors degree in Life Sciences Nursing Pharmacy/PharmD or other healthcarerelated field; equivalent education or professional experience accepted.
Advanced English (Mandatory) Advanced Spanish (preferred)
Minimum 1 year of experience in drug safety/pharmacovigilance or relevant clinical experience (training included).
Previous experience in the pharmaceutical industry preferred.
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:
Senior 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
