Glbl Safety & PV Associate I (Maternity cover dedication to Global Top Biopharmaceutical co.)

Location
Sydney, AUS
Salary
Competitive
Posted
20 Apr 2021
Closes
07 May 2021
Ref
21004859
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
JOB RESPONSIBILITIES

  • Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
  • Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
    • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
    • Enters data into safety database.
    • Codes events, medical history, concomitant medications and tests.
    • Compiles complete narrative summaries.
    • Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
    • Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
  • Ensures 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.
  • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.


QUALIFICATION REQUIREMENTS (please indicate if 'preferred')

  • Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
  • 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), TeamShare (or other management/shared content/workspace) and internet.
  • Ability to work independently and in a team environment
  • Good 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