Description
Syneos Health is seeking a Pharmacovigilance Specialist to join their team. The successful candidate will be responsible for ensuring compliance with pharmacovigilance regulations and guidelines.
Job Responsibilities
- Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs)
- Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans
- Triage ICSRs, evaluate ICSR data for completeness, accuracy, and regulatory reportability
- 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
- Perform 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
Qualifications
- Bachelor's degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience
- Safety Database systems and knowledge of medical terminology required
- Good understanding of 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
- Ability to work independently and in a team environment
- Excellent communication and interpersonal skills, both written and spoken
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Detail-oriented with a high degree of accuracy and ability to meet deadlines
About Syneos Health
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. They partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.