Description
Syneos Health is seeking a Safety & PV Coordinator - Clinical Trial Case Processing. As a member of the Clinical Solutions team, you will act with a drug development mindset, applying your years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required
- Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required
- Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory report ability
- Enter data into safety database
- Code events, medical history, concomitant medications, and tests
- Compile complete narrative summaries
- Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved
- Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements
- Maintain safety tracking for assigned activities
- Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required
- Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA
- Manually recode un-recoded product and substance terms arising from ICSRs
- Identify and manage duplicate ICSRs
- Participate in activities related to SPOR / IDMP
- Conduct quality review of ICSRs
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
- Maintain understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process
- Foster constructive and professional working relationships with all project team members, internal and external
- Participate in audits as required/appropriate
- Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities
Qualifications
- Bachelor’s Degree in Life Sciences, Nursing, Pharmacy, or an equivalent combination of education and experience that provides the necessary knowledge, skills, and abilities to perform the job
- 1+ years of experience in Clinical Trial Case Processing, including adverse event case handling, safety data review, and pharmacovigilance activities
- Experience with Safety Database systems and knowledge of medical terminology required
- Good understanding 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, Outlook, Team Share (or other shared content/workspace management tools), and internet-based applications
- Ability to work independently and in a team environment
- Excellent communication and interpersonal skills, both written and verbal
- Good organizational skills with a proven ability to prioritize and manage multiple tasks and projects simultaneously
- Detail-oriented with a high degree of accuracy and the ability to meet deadlines