Safety & PV Specialist I/II

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

📋 Description

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

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

• Assess ICSRs and analyze data for completeness, accuracy, and regulatory reportability.

• Populate safety databases with relevant information.

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

• Create comprehensive narrative summaries.

• Identify information that requires clarification and follow up until those queries are resolved satisfactorily.

• Assist in producing timely, consistent, and accurate expedited reports as per regulatory standards.

• Maintain safety tracking for designated activities.

• Conduct literature screening and safety reviews.

• Carry out drug coding and manage the drug dictionary.

• Execute MedDRA coding effectively.

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

• Manually recode any unrecoded product and substance terms from ICSRs.

• Identify and manage duplicate ICSRs appropriately.

• Engage in activities related to SPOR/IDMP.

• Perform quality reviews of ICSRs.

• Ensure pertinent documents are submitted to the Trial Master File and Pharmacovigilance System Master File as needed.

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

• Cultivate professional working relationships with both internal and external project team members.

• Participate in audits as necessary.

• Utilize Syneos Health regulatory intelligence in safety reporting activities.

⛳️ Requirements

• Bachelor’s Degree in life sciences, nursing, pharmacy, or an equivalent blend of education and experience.

• Familiarity with Safety Database systems and medical terminology.

• Strong understanding of the clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP, and regulations concerning Safety and Pharmacovigilance.

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

• Ability to operate independently as well as collaboratively within a team setting.

• Exceptional written and verbal communication skills along with interpersonal abilities.

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

• Detail-oriented with a high level of accuracy and capability to meet 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 as appropriate under the Americans with Disabilities Act.