Manager of Safety Data Exchange and Compliance

2 days ago


New York, New York, United States Daiichi Sankyo, Inc. Full time

Career Opportunities

The Manager of Safety Data Exchange and Compliance at Daiichi Sankyo, Inc. plays a critical role in ensuring the company's compliance with global PV regulations and guidelines. This includes developing and maintaining strategic partnerships with vendors, negotiating and revising contracts, and providing oversight of ICSR processing activities.

Job Description:

  • Develops and maintains strategic partnerships with vendors to ensure compliance with global PV regulations.
  • Negotiates and revises collaborative license partner safety agreements with counterparts from (license) partner companies.
  • Provides oversight of ICSR processing activities, including Safety Information submission to Health Authorities and License Partners.

Key Responsibilities:

  • Manages and negotiates contracts with partners to ensure alignment with company goals.
  • Develops governance, business continuity, quality, and vendor monitoring plans.
  • Maintains up-to-date knowledge of local, regional, and international PV regulations.

Required Skills and Qualifications:

  • Bachelor's degree in nursing, pharmacy, life sciences, healthcare, or related field.
  • Minimum 10 years of professional experience in PV required.
  • Knowledge of Adverse Event and drug coding conventions (MedDRA, WHO-DD).

Salary Range: $130,000 - $190,000 per year, depending on experience.



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