Daiichi Sankyo US · 23 hours ago
Assoc Dir Clinical Safety Risk Mgmt
Basking Ridge, NJ
Full-time
Onsite
Mid, Senior Level
$151K/yr - $226K/yr
4+ years expDaiichi Sankyo is a global healthcare company dedicated to improving lives through innovative medicines. The role involves managing risk management initiatives, providing strategic advice, and supporting global product teams in risk management planning and execution.
Health CareTherapeuticsWellness
Responsibilities
Provides expert, strategic advice on the creation and submission of RMPs and REMS
Own and maintain the process for creating RMPs
Provides expert, strategic advice on executing the requirements of RMP/REMS (including acquiring appropriate tools and competent vendors)
Guides and supports teams on tracking submissions (and following the status of submissions)
Guides in creating assessment reports
Guides and supports with the alignment of RMPs, labels in key regions (US, EU, Japan) and periodic reports
Serves as member of the Risk Management office to provide knowledge of regulator and industry trends related to risk management
May draft and/or propose changes to SOPs/SOIs related to risk management
Keeps management aware of any gaps in risk management planning, creation, and execution Lead/Manage RMP initiatives
Lead and/manage RMP initiatives and activities related to risk management planning, risk management sciences, and risk management tools and resources
Risk Management Compliance & Inspection Readiness Champion
Serve as member of Risk Management office to ensure risk management activities allow for effective preparation for inspections/audits
Serve a key support during Risk Management Inspections
Qualification
Required
Bachelor's degree in healthcare related field required
4 or more years of relevant experience in risk management and project management required
Ability to travel up to 20% of the time. Domestic and International travel
Preferred
PharmD or PhD preferred
Company
Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.
10001+ employees
H1B Sponsorship
Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (25)
2023 (19)
2022 (12)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
2025-06-01
2025-02-18
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