Drug Safety Alliance (DSA) located in Durham, N.C. is seeking talented Operations Coordinators for regular, full time positions and temporary, full time.  DSA is a full-service outsourcing provider with an exclusive focus on drug safety. Our clients are large, midsize, and emerging pharmaceutical and biotechnology companies, both domestic and international. We support over 500 pharmaceutical and biological products internationally.   DSA effectively manages a suite of services including case management, regulatory consulting, quality management, and a secure, validated safety database.

SCOPE:

Coordinates administrative activities relating to the collection, registration, processing, submission/reporting and follow-up of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational compounds.

RESPONSIBILITIES:

The Operations Coordinator position includes three functional responsibilities, Case Registration, Submissions and Follow-Up.

Case Registration:

• Manage, organize, & track detailed information from report source documents.
  
• Exhibit a working knowledge of requisite software and database to enter and track all pertinent safety information when received.
  
• Extract & interpret data from source documents, apply applicable timelines, & determine important case factors. 
  
• Assist other Operational Staff with metrics and status report generation and compilation activities.
  
• Communicate status of all Individual Case Safety Reports (ICSRs) to Project Managers, assigned team members, clients and affiliates on a regular basis.
  
• Participate in and complete data reconciliation between client clinical research database and applicable safety database (e.g., Clintrace, ARGUS, ARIS-g, Oracle AERS), compare database information and request additional clarification.
  
• Act as cross-functional back-up for all other Case Registration, Submissions and Follow-Up Coordinators.

Submissions Coordinator:

• Process all submissions according to all applicable SOPs, WPs and client-specific conventions.
  
• Extract data, apply applicable timelines, interpret data from source documents to determine important case factors
  
• Communicate status of all submission activities to Project Managers and assigned team members on a regular basis.
  
• Produce and communicate metrics to the Quality Regulatory Compliance department (e.g., late reports, missed workflow timelines, case load, workflow problems).
  
• Assist in providing submission/project work for the following: IND Annual Reports, Periodic Safety Reports, 15-Day Alert Reports, IND SR including investigator letters and cover letters to regulatory authorities.
  
• Act as cross-functional back-up for all other Submissions, Follow-Up, and Case Registration Coordinators.

Follow-Up Coordinator:

• Process follow-up letters for domestic cases according to the follow-up worksheet and applicable SOPs, WPs and client-specific conventions.
  
• Track all follow-up activities and communicate status of all follow-up activities to Project Managers and assigned team members on a regular basis.
  
• Suppress cases in DSA adverse event database following the standard practices.
  
• Act as cross-functional back-up for all other Follow-Up, Submissions and Case Registration Coordinators.

Perform other duties as assigned.

QUALIFICATIONS:

·         An Associate’s degree or Bachelor’s degree and a minimum of 2 years industry experience is preferred.

·        Must have strong, demonstrated administrative and data entry skills.

·         Ability to manage multiple activities and assignments.

·         Ability to work both as a member of a team and in an independent, self-directed manner.

·         Proven experience managing and organizing work to meet strict timelines and to meet the attention of detail required to successfully complete assignments.

·         Ability to communicate effectively in English, both verbally and in writing; ability to maintain client and corporate confidentiality.

·         Ability to interpret and follow SOPs and WPs; utilize sound decision-making skills to solve problems and troubleshoot issues in the area of expertise and job assignment.

·         Ability to proficiently utilize MS Office including Excel, MS WORD and other required software; and ability to assess and follow algorithms and workflow diagrams with timelines and notification details. 

·         A working knowledge of regulatory package preparation is a plus.

Drug Safety Alliance offers competitive compensation, an attractive benefits package, the opportunity for professional advancement, and career growth.  If you meet the position requirements and are seeking an opportunity to contribute in a dynamic, small company environment, please submit a resume and salary history to email your resume to:   careers@drugsafetyalliance.com     Drug Safety Alliance is an Equal Opportunity Employer.