Safety & PV Specialist I

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Input data into PVG quality and tracking systems for the receipt and monitoring of ICSRs as required.

• Aid in processing ICSRs in accordance with SOPs and specific safety plans for projects/programs.

• Assess ICSRs and determine data completeness, accuracy, and regulatory reportability.

• Populate the safety database with relevant data.

• Code events, medical histories, concomitant medications, and tests accurately.

• Compile thorough narrative summaries.

• Identify information requiring clarification and ensure follow-up until queries are resolved satisfactorily.

• Assist in producing timely, consistent, and precise expedited reports per regulatory requirements.

• Maintain safety tracking for designated activities.

• Conduct literature screening and reviews for safety, drug coding, drug dictionary maintenance, and MedDRA coding.

• Validate and submit xEVMPD product records, including coding indication terms using MedDRA.

• Manually recode product and substance terms that have not been coded from ICSRs.

• Detect and manage duplicate ICSRs effectively.

• Undertake activities related to SPOR / IDMP.

• Perform quality reviews of ICSRs.

• Ensure all relevant documents are submitted to the TMF and Pharmacovigilance System Master File as necessary.

• Uphold compliance with SOPs, WIs, global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process.

• Cultivate professional relationships with project team members.

• Participate in audits as necessary.

• Utilize Syneos Health regulatory intelligence in safety reporting activities.

⛳️ Requirements

• Bachelor’s Degree in life science, nursing, pharmacy, or a comparable combination of education and experience that provides the necessary knowledge, skills, and abilities to fulfill the role.

• Experience with Safety Database systems and a strong understanding of medical terminology is essential.

• Solid grasp of the clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP, and regulations related to Safety and Pharmacovigilance.

• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace), and internet navigation.

• Capacity to work autonomously as well as collaboratively in a team setting.

• Exceptional communication and interpersonal skills, both written and verbal.

• Strong organizational abilities with a proven track record of prioritizing and managing multiple tasks and projects effectively.

• Detail-oriented with a high level of accuracy and the ability to adhere to deadlines.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when necessary.