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Safety Associate

Safety Associate

Safety Associate

Accentuate Staffing is searching for a Safety Associate to join a pharmaceutical company in Durham, NC.  This is a Direct Hire role that is responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, standard operating procedures and project-specific instructions.

Responsibilities:

  • Author Safety Management Plan for assigned studies
  • Configures and participates in validation of safety database systems
  • Attend internal and client meetings as appropriate
  • Attend and present at Investigator Meetings
  • Identify, track, and file potential adverse event (AE) information.
  • Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
  • Responsible for monitoring all incoming information and identification of potential AE information and assembling data for team meetings
  • Participates in the case narrative generation, review and refinement process depending upon level of experience.
  • Conducts several rounds of query and response (back to site) under the guidance of Medical reviewers to gain complete and accurate case information.
  • Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
  • Processes all field and narrative case data entry.
  • Processes all Adverse Effects (AE), medical history and con meds coding.
  • Ensures that all international regulations are followed regarding pharmacovigilance procedures.
  • Perform quality control activities including the review of source documents and case data to verify accuracy and consistency as well as to ensure compliance with timelines and quality standards
  • Participates as a cross functional team member of project team.
  • Participates in Serious Adverse Event (SAE) Reconciliation activities with the SAE information in the clinical trial database.
  • Performs periodic Global Safety Database searches to support inquiries from stakeholders as required.
  • Prepare and submit periodic safety reports as needed. May assist in the creation of ad hoc safety reports for submission to relevant stakeholders both inside and external
  • Reviews all cases for completeness and accuracy of data versus available source documents.
  • Ensures that in all received and created documentation, that patient privacy and confidentiality of identity be maintained and recommends steps that should be taken to avoid or mitigate breaches.
  • Represent Safety Management on customer and project teams and in meetings.
  • Monitor and report key performance indicators as appropriate.
  • Authoring Standard Operating Procedures (SOPs) and Work Practice Instructions.

Requirements:

  •  BS or equivalent in life science or related field
  • 2-3 years industry experience in Safety Management/Pharmacovigilance for a pharma, biotech, and/ or contract/academic research organization.
  • Experience with drug safety databases, case processing and MedDRA coding concepts.
  • Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint).
  • Experience with Oracle Argus preferred
  • Expected travel time is up to 20% for this position. The role requires international travel as needed to support business needs.
  • Good understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements
  • Good understanding of computer technology, and management of relational database systems, including extraction of data
  • Demonstrated understanding of global pharmaceutical drug development and drug lifecycles.
  • Direct experience reviewing and/or authoring standard operating procedures.
  • Established client facing communication skills – ability to manage situations, negotiate conflicts, and influence others to achieve objectives
  • Strong follow-up and organizational skills.
  • Strong problem solving/process improvement skills with ability to be part of and own solutions.
  • Drive to seek solutions with intent and priority through a balance of creativity and restraint.
  • Expected and empowered to make decisions without direct supervision. Ability to work well independently and within a team.
  • Handle confidential and sensitive matters with discretion.

 

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