Associate Manager, Compliance, Training & Strategic Alliance

September 16

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Sumitomo Pharma America, Inc.

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1001 - 5000

Description

• Manage the Pharmacovigilance (PVRM) and non-PVRM vendor(s). • Responsible for adverse event handling and reporting. • Support of global PV system operations. • Develop and maintain PV staff learning plans. • Assist with compliance activities and quality monitoring. • Conduct audit and inspection preparedness.

Requirements

• Bachelor's degree preferably in a scientific, regulatory, or health-related field. • 2-3 years of experience specific to Pharmacovigilance operations and compliance. • Strong understanding of U.S. regulations and guidance, and fundamental working knowledge of global regulations.

Benefits

• Merit-based salary increases. • Short incentive plan participation. • Eligibility for 401(k) plan. • Medical, dental, vision, life and disability insurances. • Unlimited paid time off. • 11 paid holidays. • Additional time off for a shut-down period. • 80 hours of paid sick time upon hire and annually thereafter.