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Drug Safety Associate (DSA)

Cambridge, Massachusetts

Post Date: 07/24/2017 Job ID: 1564 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety

The Drug Safety and Pharmacovigilance (DSPV) Group is seeking a Drug Safety Associate (DSA). The DSA will provide technical and process-related support for all as aspects of drug safety case management (processing and reporting) for investigational compounds and marketed products. In addition, this role may serve as a liaison to external stakeholders (Partners) on Safety related matters and policy including activities such as case management, compliance, Partner Pharmacovigilance (PV) agreements, aggregate reporting and global risk management of products.  

DSPV has a vendor to externally host its Safety Database (SD).  The DSA will play a key role in supporting the existing implementation, legacy migration and business support model for an externally hosted Oracle Argus Safety System.  The safety system enables the exchange safety data between multiple Partners and Regulatory authorities and supports DSPV in global responsibilities including aggregate data exploration, periodic reporting and data mining/safety signaling activities.  The DSA role may assist with system validation activities as well as will provide input on continuous process improvement of the system’ s functionality, system and business process change control, documentation of processes such as Standard Operating Procedures (SOPs) and update/development of training materials in accordance with relevant global regulations and SOPs.   

Job  Responsibilities:
  • Provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
  • Ensure accurate transfer of information from initial and follow-up source documents or E2B inputs for adverse event reports to appropriate fields within Argus; code adverse events using MedDRA, create narrative of the adverse events, and manage case reports within the Argus workflow to meet local and global regulatory timelines
  • Process case-related information including interpretation of medical conditions, lab results, and procedures; ensuring proper coding of data into the global safety database
  • Correspond and interface with CRO’ s regarding collection of safety information for development products
  • Assist with SAE reconciliation activities with internal departments and external partners as needed
  • Ensure timely preparation & submission of reports to regulatory agencies in accordance with applicable regulations - including United States DSUR and global PBRER reports
  • Review literature citations weekly for appropriate reporting and collection of safety information for both marketed and development products
  • Assist in development of project specific safety procedures, workflows and templates
  • Assist in project specific safety database setup, development of data entry guidelines, user acceptance testing, policies and training materials
  • Create and maintain project specific working files, case report files and project central files
  • Participate in audit preparedness and support Partner and/or Regulatory audit
  • Reports into DSPV and may serve as a project team member within cross-functional team members from DSPV, Clinical Operations (ClinOps), Biometrics, Data Management, Quality Assurance (QA), Documentation Management and Informational Technology (IT) and provide leadership, coordination and communication on Safety related matters

Qualifications:
  • Scientific degree Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience. 
  • Minimum 3 – 5 years’ experience in Pharma industry with 2 -4 years Drug Safety experience
  • Knowledge and experience working with Oracle Argus is preferable
  • Proven ability to work well with others in a proactive, positive, and constructive manner. A positive attitude for driving ambiguous situations.
  • Analytical and organizational ability, able to prioritize with problem solving skills under minimal supervision
  • Good clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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