Asahi Kasei
  • AK Pharma America
  • Waltham, MA, USA
  • Full Time

Very strong medical, dental, disability and company matched 401(K)

Asahi Kasei Pharma America (AKPA) is recruiting for a Drug Safety/Pharmacovigilance Specialist. This newly created role offers the qualified candidate an opportunity to contribute to overall success and efficiency of Drug Safety & PV function within AKPA.

The Drug Safety/Pharmacovigilance Specialist will be responsible for case processing of serious adverse events for clinical trial and marketed products. We will require the qualified candidate to utilize their medical background to write comprehensive case narratives for complex clinical cases in addition to interacting with study sites and CRO partners to obtain missing information. We utilize the ARISg safety database and this role will enter case information into the database as needed. Familiarity with ARISg is a plus.

Additionally, the Drug Safety/Pharmacovigilance Specialist will assist with SUSAR regulatory submissions as well as periodic reporting including DSURs. This role will also review and QC cases processed by other staff members and participate in the development of protocols, investigator brochures, safety forms and other documents.

This position operates in an environment that demands strong attention to detail, as well as strong organization, prioritization and problem solving skills.

Experience and Qualifications

  • Healthcare related education (nursing is ideal)

  • 2+ years of experience in a clinical setting

  • Able to work constructively in a matrix environment.

  • 2+ years of experience with safety case management including:

    • Safety database(s)

    • MedDRA/WhoDrug coding

    • Narrative writing " complex clinical cases (critical care, oncology)

    • Query generation

    • SAE reconciliation

  • Self-motivated, pro-active with strong technical skills in all MS Office Suite programs.

  • Working knowledge of US and global clinical trial safety regulatory reporting requirements.

Asahi Kasei
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