Clinical Operations

  • location: San Francisco, CA
  • type: Contract
  • salary: $43.07 - $50.68 per hour
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job description

Clinical Operations

Drug Safety Specialist III

Job Responsibilities

  • 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.
  • Ensures the uniform and timely processing of adverse event reports.
  • Develops and prepares reports for company management as well as external regulatory agencies.
  • May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.
  • Performing complete data entry of serious adverse events received from clinical trials, according to the the client's 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, 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.
  • Draft appropriate queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior client Drug Safety person.
  • Communicate or notify the client's drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.
  • Maintain and track all serious adverse events reported from the client's sponsored clinical trials for case processing relative to their priorities and submission deadlines.
  • 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.
  • Ensure compliance with the client's SOPs.
Education & Qualifications

  • A Bachelors degree in a scientific discipline is preferred.
  • RN or BSN degree is highly desired.
  • Equivalent experience may be accepted.
  • A minimum of six years experience in Drug safety or Pharmacovigilance, with at least two years 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.
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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