Drug Safety Monitoring Specialist

Cambridge, MA

Posted: 11/29/2023 Industry: Scientific Job Number: 23-00589

Job Description

  • Maintain oversight of safety risk management and all other pharmacovigilance (PV) activities across all affiliate functions
  • May participate as a liaison, speaking to healthcare providers and consumers regarding the commercial product.
  • Project managment through tracking and driving deadlines for metrics, reports, and other targets
  • Ensure relevant literature systematic review to collect AEs in local journal and/or for local marketed products not included in the global literature search
  • Reporting safety information to the Global Drug Safety and local regulatory authority within specified timelines
  • Ensure constant compliance to the local and global Standard Operating Procedures
  • Acts as a safety representative and facilitator between external reporting sources
  • Assist in responding to queries from health authorities or outside sources
  • Management and submission of Individual Case Safety Report from all Spontaneous and Solicited sources
  • Bachelor's degree in Medicine
  • PharmD degree preferred
  • 5+ years of medical monitoring experience
  • Pharma, chem, or immunology background
  • Experience with late phase trials
  • PV oncology background preferred
  • Proficient in Computer System Validation (CSV)
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

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Alyssa Darden

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