Sr. Drug Safety Specialist

San Francisco, CA 94107

Posted: 07/05/2019 Employment Type: Contract Industry: Research Job Number: 6506
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.

Duties:
  • Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies.
  • Develops guidelines and insures the uniform and timely processing of adverse event reports.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
  • Develops and prepares reports for company management as well as external regulatory agencies.
  • Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary.
  • May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.

Skills:
  • Perform standard quality check of data entry of serious adverse events or other documents as requested.
  • Perform complete data entry of serious adverse events based on information received from reporters per source document, and according to the workflow processes and standard operating procedures.
  • Generate accurate and complete case narratives based on information received as part of source documents including but not limited to SAE report forms, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites.
  • Follow-up with investigators and clinical study personnel regarding queries for outstanding information or incomplete data to ensure case completeness within acceptable timelines.
  • Promptly escalate study site non-compliance with request for outstanding information, to the appropriate senior drug safety personnel.
  • Root cause analysis and investigation of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.
  • Initiate corrective and preventive action (CAPA) measures following review of root cause analysis with senior drug safety personnel.
  • Maintain and track all CAPAs related to the Comany' s Drug Safety.
  • Support Drug Safety Department initiatives on ad hoc (as needed) basis.
  • Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events.
  • Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally.


Education:
  • A Bachelor' s degree in a scientific discipline is required.
  • RN or BSN degree is highly desired.
  • Equivalent experience may be accepted.
  • A minimum of eight years experience in Drug safety or Pharmacovigilance, with at least four year’ s hands-on experience in serious adverse event management in clinical trials evaluating investigational products is required.
  • Experience in oncology therapeutic area is preferred but not mandatory.
  • Familiarity with Medical terminology required.
  • Ability to process data entry accurately.
  • Ability to code and map data accurately.
  • Concise case narrative (medical) writing experience preferred.
  • Ability to prioritize work without much support.
  • Clear effective written and verbal communication skills are essential for effective communication with study sites.
  • Focused and detail oriented.
  • Work effectively as a team member, promote collaboration.
  • Self starter and self accountability.
  • Relevant industry experience is highly preferred.
  • High level of work conduct.
Skills:
  • Perform standard quality check of data entry of serious adverse events or other documents as requested.
  • Perform complete data entry of serious adverse events based on information received from reporters per source document, and according to the workflow processes and standard operating procedures.
  • Generate accurate and complete case narratives based on information received as part of source documents including but not limited to SAE report forms, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites.
  • Follow-up with investigators and clinical study personnel regarding queries for outstanding information or incomplete data to ensure case completeness within acceptable timelines.
  • Promptly escalate study site non-compliance with request for outstanding information, to the appropriate senior drug safety personnel.
  • Root cause analysis and investigation of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.
  • Initiate corrective and preventive action (CAPA) measures following review of root cause analysis with senior drug safety personnel.
  • Maintain and track all CAPAs related to the Comany's Drug Safety.
  • Support Drug Safety Department initiatives on ad hoc (as needed) basis.
  • Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events.
  • Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally.


Education:

  • A Bachelor's degree in a scientific discipline is required.
  • RN or BSN degree is highly desired.
  • Equivalent experience may be accepted.
  • A minimum of eight years experience in Drug safety or Pharmacovigilance, with at least four year’s hands-on experience in serious adverse event management in clinical trials evaluating investigational products is required.
  • Experience in oncology therapeutic area is preferred but not mandatory.
  • Familiarity with Medical terminology required.
  • Ability to process data entry accurately.
  • Ability to code and map data accurately.
  • Concise case narrative (medical) writing experience preferred.
  • Ability to prioritize work without much support.
  • Clear effective written and verbal communication skills are essential for effective communication with study sites.
  • Focused and detail oriented.
  • Work effectively as a team member, promote collaboration.
  • Self starter and self accountability.
  • Relevant industry experience is highly preferred.
  • High level of work conduct.
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