assist with safety and pharmacovigilance program delivery activities including collection, processing, and reporting of individual cases safety reports (ICSRs)
literature screening for safety, drug coding, maintenance of drug dictionary, MedDRA coding
data management activities including cleaning and validation of data
identification of Medicinal Products (IDMP) activities and preparation of expedited and periodic safety reports
adheres to data privacy guidelines, GCP, GVP, regulatory guidelines, company and project/program-specific procedures
enter information into PVG quality and tracking systems for receipt and tracking ICSR
assist in the processing of ICSRs according to SOPs
triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability
maintains safety tracking for assigned activities
performs literature screening and review for safety
ensures all relevant documents are submitted to the Trial Master File (TMF)
participates in audits as required/appropriate

Bachelor’s Degree in life science, registered nurse, pharmacist or equivalent combination of education and experience
3+ years of experience in ICSR case processing
Advanced MedDRA coding training
knowledge of medical terminology
Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet
Excellent communication and interpersonal skills, both written and spoken
good English level
Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
Detail oriented with a high degree of accuracy

Safety & PV Specialist I

Key skills