Safety & PV Specialist I

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs • Assist in processing ICSRs according to SOPs and project/program-specific safety plans • Triage ICSRs and evaluate data for completeness, accuracy, and regulatory reportability • Enter data into the safety database • Code events, medical history, concomitant medications, and tests • Compile complete narrative summaries • Identify information to be queried and follow up until queries are satisfactorily resolved • Assist with timely, consistent, and accurate expedited safety reporting • Maintain safety tracking for assigned activities • Perform literature screening and review for safety • Perform drug coding and maintain the drug dictionary • Perform MedDRA coding • Validate and submit xEVMPD product records, including coding indication terms using MedDRA • Manually recode un-recoded product and substance terms from ICSRs • Identify and manage duplicate ICSRs • Perform activities related to SPOR/IDMP • Conduct quality review of ICSRs • Ensure relevant documents are submitted to the TMF and Pharmacovigilance System Master File as appropriate • Maintain compliance with SOPs, WIs, regulations, GCP, ICH guidelines, GVP, project/program plans, and the drug development process • Foster professional working relationships with project team members • Participate in audits as required • Apply Syneos Health regulatory intelligence to safety reporting activities

🎯 Requirements

• Bachelor’s Degree in life science, registered nurse, pharmacist, or equivalent combination of education and experience • Safety Database systems knowledge required • Knowledge of medical terminology required • Good understanding of clinical trial processes across Phases II–IV and/or post-marketing safety requirements • Understanding of ICH GCP, GVP, and safety/pharmacovigilance regulations • Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint • Proficiency in Visio • Proficiency in Outlook email • Proficiency in Team Share or another management/shared content/workspace system • Ability to work independently and in a team environment • Excellent written and spoken communication and interpersonal skills • Good organizational skills and ability to prioritize multiple tasks and projects • Detail-oriented, highly accurate, and able to meet deadlines

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Diverse career paths and employment opportunities • Reasonable accommodations when appropriate