Safety & PV Specialist I
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Safety & PV Specialist I based in Brazil.
This is an opportunity to support critical pharmacovigilance and safety activities within a global life sciences environment.
The role focuses on the accurate and timely processing, review, coding, and tracking of Individual Case Safety Reports (ICSRs).
You will contribute to regulatory reporting, safety database activities, literature screening, and product data management.
The position combines technical precision, regulatory awareness, and close collaboration with international project teams.
You will work across clinical trial and post-marketing safety activities while following established SOPs and global guidelines.
Attention to detail, organization, and sound judgment will be essential to maintaining data quality and patient safety.
The role offers a remote work environment and exposure to diverse projects within the biopharmaceutical industry.
Accountabilities
Enter, track, and maintain pharmacovigilance information in quality and safety tracking systems, supporting the receipt and processing of ICSRs.
Triage and review ICSRs for completeness, accuracy, and regulatory reportability, and enter relevant information into safety databases.
Code adverse events, medical history, concomitant medications, tests, products, and other safety information using applicable medical terminology and coding standards.
Prepare complete and accurate case narratives, identify missing information, and follow up on queries until they are appropriately resolved.
Support the timely generation and reporting of expedited safety reports in accordance with regulatory requirements, SOPs, and project-specific safety plans.
Perform literature screening and review activities, including drug coding, MedDRA coding, and maintenance of relevant drug dictionaries.
Support xEVMPD product record validation and submission, including appropriate coding of indication terms.
Perform manual recoding of unrecognized product and substance terms and identify and manage duplicate ICSRs.
Contribute to SPOR/IDMP-related activities and conduct quality reviews of ICSRs.
Ensure relevant documentation is submitted to the appropriate Trial Master File (TMF) or Pharmacovigilance System Master File according to applicable requirements.
Maintain safety tracking for assigned activities and participate in audits when required.
Apply current safety-reporting regulatory intelligence to assigned activities while maintaining compliance with SOPs, work instructions, GCP, ICH, GVP, and applicable global regulations.
Collaborate professionally with internal and external project stakeholders across clinical and pharmacovigilance teams.
Bachelor’s degree in a life science discipline, or qualification as a registered nurse, pharmacist, or equivalent combination of education and relevant experience.
Experience or knowledge of safety database systems and medical terminology.
Good understanding of clinical trial processes across Phases II-IV and/or post-marketing safety requirements.
Knowledge of ICH GCP, GVP, and regulations applicable to safety and pharmacovigilance activities.
Proficiency with Microsoft Office tools, including Word, Excel, and PowerPoint, as well as collaboration, document-management, email, and internet-based platforms.
Strong attention to detail and a high degree of accuracy when handling safety and regulatory information.
Excellent written and verbal communication and strong interpersonal skills.
Ability to work independently while collaborating effectively within a team environment.
Strong organizational and prioritization skills, with the ability to manage multiple activities and projects while meeting deadlines.
Ability to follow standardized processes and apply regulatory and project-specific requirements consistently.
Remote work opportunity in Brazil.
Full-time position within a global life sciences and healthcare environment.
Career development and progression opportunities.
Supportive and engaged line management.
Technical and therapeutic-area training.
Peer recognition and total rewards programs.
Opportunities to collaborate with international, multidisciplinary teams.
Exposure to clinical development, pharmacovigilance, regulatory requirements, emerging technologies, data, and scientific knowledge.
Opportunities for professional growth across different functions and therapeutic areas.