Compliance & PV Operations Manager

New

Skills

Vendor Management

Sumitomo Pharma America, Inc. is committed to advancing global health through innovative treatments and technology in critical therapeutic areas such as psychiatry, neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co., Ltd., we integrate technology and life sciences expertise to deliver patient-first solutions. We are seeking an Associate Manager, Compliance, Training & Strategic Alliance to oversee pharmacovigilance operations, vendor management, and ensure regulatory compliance within our dynamic team.

Key Responsibilities
  • Manage Pharmacovigilance (PVRM) and non-PVRM vendors to ensure contractual obligations are met.
  • Oversee adverse event handling, reporting, and general PVRM operations.
  • Support the PV Operations Manager with operational deliverables and projects.
  • Develop and maintain strategic relationships with vendors, ensuring quality and performance.
  • Conduct routine case quality checks and assist the IM team with ad-hoc initiatives.
Required Skills & Qualifications
  • Bachelor's degree in a scientific, regulatory, or health-related field preferred.
  • 2-3 years of biotech or pharmaceutical industry experience in Pharmacovigilance operations and compliance.
  • Comprehensive understanding of FDA, Health Canada, and international pharmacovigilance regulations.
  • Proficiency in end-to-end case management for clinical trial and post-market ICSRs.
  • Experience supporting partner audits and regulatory inspections (FDA, MHRA, EMA).
  • Skilled in ARGUS, MedDRA, WHODD, MS Office Suite, SharePoint, and Veeva systems.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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