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Drug Safety Operations Coordinator

Ascent Services Group

Job Description

Drug Safety Operations Coordinator
Bothell, WA
6+ Month Contract
Targeting $20.00/hour
 
Summary:
The Drug Safety Operations Coordinator is responsible for the facilitation of the workflow of serious adverse event (SAE) reports for investigational products and adverse event (AE) reports for marketed products. This position manages the intake of all safety information received by Drug Safety Operations and tracks timelines to ensure compliance of safety reporting to business partners and Health Authorities. In addition, this position collaborates with various teams in Drug Safety Operations to develop and enhance Drug Safety processes and procedures.
 
Requirements:
  • Strong communication (verbal and written) skills
  • Demonstrated knowledge and understanding of domestic and international regulatory safety reporting requirements
  • 2+ years of comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs
  • Excellent organizational skills and attention to detail
  • Excellent interpersonal skills, including the ability to work effectively cross-culturally and cross-functionally
Education:
  • Junior-level college degree or equivalent training
Responsibilities:
  • Manage the workflow of all safety information received into the department to facilitate routing, review, approval, and timely case finalization, submission, and archiving
    Intake and documentation of receipt of safety reports, follow-up information, and source documents
  • Send team notifications of receipt of safety information in accordance with Safety Management
  • Plan timelines
  • Data entry of basic fields into Drug Safety Database
  • Preliminary coding of all adverse event terms
  • Assess reports for follow-up reporting requirements
  • Oversee the progression of cases through departmental workflow and ensure timely completion of submissions and case closure procedures
  • Manage timelines for reporting Individual Case Safety Reports (ICSR) to pertinent regulatory agencies to ensure that global regulatory reporting requirements are met
  • Implement and manage the filing (electronic and hardcopy) of all documents associated with the collection, preparation, and reporting of SAEs for all in house studies and/or partnered studies and/or CRO managed studies
  • Collaborate to maintain, develop and/or enhance departmental work procedures
  • Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
  • Perform other duties related to the position as required

Job Requirements

 
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Job Snapshot

Location US-WA-Bothell
Employment Type Contractor
Pay Type Hour
Pay Rate $0.00 - $20.00 /Hour
Store Type Other

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Snapshot
Ascent Services Group
Company:
US-WA-Bothell
Location:
Contractor
Employment Type:
Hour
Pay Type:
$0.00 - $20.00 /Hour
Pay Rate:
Other
Store Type:

Job Description

Drug Safety Operations Coordinator
Bothell, WA
6+ Month Contract
Targeting $20.00/hour
 
Summary:
The Drug Safety Operations Coordinator is responsible for the facilitation of the workflow of serious adverse event (SAE) reports for investigational products and adverse event (AE) reports for marketed products. This position manages the intake of all safety information received by Drug Safety Operations and tracks timelines to ensure compliance of safety reporting to business partners and Health Authorities. In addition, this position collaborates with various teams in Drug Safety Operations to develop and enhance Drug Safety processes and procedures.
 
Requirements:
  • Strong communication (verbal and written) skills
  • Demonstrated knowledge and understanding of domestic and international regulatory safety reporting requirements
  • 2+ years of comparable experience in the pharmaceutical industry experience preferably in one or more of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs
  • Excellent organizational skills and attention to detail
  • Excellent interpersonal skills, including the ability to work effectively cross-culturally and cross-functionally
Education:
  • Junior-level college degree or equivalent training
Responsibilities:
  • Manage the workflow of all safety information received into the department to facilitate routing, review, approval, and timely case finalization, submission, and archiving
    Intake and documentation of receipt of safety reports, follow-up information, and source documents
  • Send team notifications of receipt of safety information in accordance with Safety Management
  • Plan timelines
  • Data entry of basic fields into Drug Safety Database
  • Preliminary coding of all adverse event terms
  • Assess reports for follow-up reporting requirements
  • Oversee the progression of cases through departmental workflow and ensure timely completion of submissions and case closure procedures
  • Manage timelines for reporting Individual Case Safety Reports (ICSR) to pertinent regulatory agencies to ensure that global regulatory reporting requirements are met
  • Implement and manage the filing (electronic and hardcopy) of all documents associated with the collection, preparation, and reporting of SAEs for all in house studies and/or partnered studies and/or CRO managed studies
  • Collaborate to maintain, develop and/or enhance departmental work procedures
  • Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
  • Perform other duties related to the position as required

Job Requirements

 
Drug Safety Operations Coordinator Apply now