Senior Associate, Pharmacovigilance Coordinator Job at Cogent Biosciences, Waltham, MA

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  • Cogent Biosciences
  • Waltham, MA

Job Description

Cogent Biosciences seeks a Senior Associate to coordinate daily pharmacovigilance operations, including inbox management, case tracking, vendor oversight, and regulatory compliance documentation. This hands-on role supports a growing safety team managing adverse event reporting and data integrity for clinical development programs.

Responsibilities

  • Monitor and triage the pharmacovigilance mailbox daily; route safety information and requests to appropriate owners
  • Log incoming items, track closure status, and escalate time-sensitive safety information to leadership
  • Track individual case safety reports through vendor workflows from receipt to regulatory submission
  • Maintain the pharmacovigilance deliverable calendar and send reminders for reports, reconciliations, and vendor outputs
  • Support adverse event reconciliations across commercial sources and maintain audit-ready documentation and sign-offs

Requirements

  • Strong organizational and attention-to-detail skills
  • Experience in pharmacovigilance operations or safety data management
  • Ability to manage multiple tasks and meet strict regulatory timelines
  • Proficiency with document management systems and databases
  • Knowledge of adverse event case processing workflows
  • Excellent communication and cross-functional collaboration skills

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