Drug Safety Associate
Covance Inc
Tokyo, Japan
1 日前

Job Overview :

  • Manage the receipt, processing and quality review of expedited safety reports (ESRs) to Japan PMDA. This includes, but is not limited to
  • maintenance of adverse event tracking systems
  • set-up and maintenance of project files, core process files and central safety files
  • contact with Regulatory Authorities, project teams and with clients to support safety reporting activities
  • Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
  • This includes, but is not limited to : entry of safety data onto adverse event database(s) and tracking systemsreview of adverse events for completeness, accuracy and appropriateness for expedited reportingwrite patient narrativescode adverse events accurately using MedDRAdetermine expectedness / listedness against appropriate labelidentifies clinically significant information missing from initial reports and ensures its collectionensure case receives appropriate medical reviewprepare follow-up correspondence consulting the medical staff accordingly.

    ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelinesreporting of endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines

  • Maintain a strong understanding of Covance’s safety database conventions or client specific database conventions, as appropriate.
  • Begin participating in signal detection and trend and pattern recognition activities, as appropriate.
  • Begin preparing timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events
  • Assist in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic Safety Update Reports (PSURs).
  • Work with Data Management or client on reconciliation of safety databases.
  • Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data provided.
  • Support / train less experienced safety staff in all aspects of case-handling, adverse event reporting.
  • Maintains a comprehensive understanding of Covance Safety’s Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
  • Possess knowledge of other procedural documents, e.g., SOPs, etc. that impact Safety.
  • Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.
  • Build and maintain good PSS relationships across functional units.
  • Demonstrate role-specific Competencies on a consistent basis.
  • Demonstrate company Values on a consistent basis.
  • Begin to develop a good knowledge of contract assumptions; identifying out of scope work.
  • Read and understand Safety Management Plans (SMPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.
  • Begin participating in Covance project teams and client meetings as appropriate.
  • Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients.
  • Assist with the set-up of, and the provision of data to, Safety Committees / DSMBs.
  • Assist in the co-ordination of endpoint committees, as required.
  • Any other duties as assigned by management.
  • Education / Qualifications :

    Required :

  • Non-degree + 4-5 yrs relevant experience (or 2 yrs safety experience)*
  • Associates Degree + 3-4 yrs relevant experience (or 1-2 yrs safety experience)*
  • Associate degree RN + 2-3 yrs relevant experience (or 1-2 yrs safety experience)*
  • BS / BA + 1-2 yrs relevant experience
  • MS / MA + 0 yr relevant experience
  • PharmD + 0 yrs relevant experience
  • Degree preferred to be in one or more of the following disciplines : Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.

  • Safety experience includes actual experience processing AE / SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
  • Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.

    Experience :

  • High degree of accuracy with attention to detail.
  • Functions as a team player.
  • Good Communication both of Japanese and English.
  • Knowledge of medical and drug terminology desirable.
  • Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation.
  • Familiarity with ICH Guidelines
  • Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
  • Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
  • Good written and verbal communication skills.
  • Ability to work independently with moderate supervision.
  • Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
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