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Manager Clinical Safety Scientist
1 week ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. Summary · • This position supports proactive safety surveillance and risk manage ...
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Manager Clinical Safety Scientist
2 days ago
Daiichi Sankyo Basking Ridge, United States Full timeJoin a Legacy of Innovation 110 Years and Counting · Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. · Summary · • This position supports proactive safety surveillance and risk management for a ...
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Manager Clinical Safety Scientist
1 week ago
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. Summary · •This position supports proactive safety surveillance and risk man ...
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Director, Clinical Safety MD
2 weeks ago
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...
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Clinical Safety Scientist Lead
3 weeks ago
The Fountain Group LLC Basking Ridge, United Statescurrently seeking a Clinical Safety Scientist Lead for a prominent client of ours. This position is located in Basking Ridge, NJ. Details for the position are as follows: · Job Description:Hybrid Shift: Manager is looking for someone to come onsite 1-2 days a week. Glob ...
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Director, Clinical Safety MD
3 weeks ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
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Richmond University Medical Center Staten Island, United States**Job Title**: Patient Safety and Clinical Effectiveness Coordinator · **Location**: Richmond University Medical Center, Quality and Safety Division · **Position Summary**: · Responsible for auditing and quality assurance review to ensure clinical data is complete and accurate. · ...
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Associate Director, Clinical Safety MD
1 week ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
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Associate Director, Clinical Safety MD
1 week ago
Daiichi Sankyo Inc. Basking Ridge, United States**Join a Legacy of Innovation 110 Years and Counting** · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class ...
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Associate Director, Clinical Safety MD
3 weeks ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
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Associate Director, Clinical Safety MD
1 week ago
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...
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Director, Medical Review
2 weeks ago
Daiichi Sankyo, Inc. Basking Ridge, United StatesJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
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Billing Coordinator
3 weeks ago
IVI America Basking Ridge, United States**Responsibilities include**: · - Maintain patient accounts by obtaining, recording, and updating the patients' personal, financial and insurance information · - Document progress and office notes in the EMR and /or billing system · - Document services to be billed by collecting ...
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Manager, Statistical Programming
1 week ago
Regeneron Pharmaceuticals Inc. Basking Ridge, United StatesThe Manager Statistical Programmer will lead and support all programming activities per the project strategies within therapeutic area(s). They will work with management and study team, plan and own the implementation and execution of programming project standard to support from ...
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Manager Clinical Safety Scientist
3 weeks ago
Daiichi Sankyo, Inc. New Jersey, United StatesJoin a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion · We are an equal opportunity employer including veterans and people with disabilities · Summary · •This position supports proactive safety surveillance and risk management for as ...
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Clinical Research Associate I Safety
3 weeks ago
Mount Sinai Medical Center New York, United States· The Clinical Research Associate is an integral part of the research study team and monitors all safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for collecting, assessing and process ...
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Clinical Research Associate I Safety
1 week ago
Mount Sinai Hospital New York, United StatesJob Description · The Clinical Research Associate is an integral part of the research study team and monitors all safety aspects of clinical research trial(s). Under guidance of the Associate Director of Research and Quality Outcomes, the CRA is responsible for collecting, assess ...
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Richmond University Medical Center Staten Island, United StatesThe Patient Safety and Clinical Effectiveness Coordinator is the accountable leader for direct facilitation of patient safety clinical reporting optimization and integration activities with an emphasis on connection within the Electronic Medical Reco Clinical, Manager, Patient, C ...
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Richmond University Medical Center Staten Island, United StatesJob Title: Patient Safety and Clinical Effectiveness Coordinator · Location: Richmond University Medical Center, Quality and Safety Division · Position Summary: · The Patient Safety and Clinical Effectiveness Coordinator is the accountable leader for direct facilitation of pat ...
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Associate Director, Clinical Safety MD
2 weeks ago
Daiichi Sankyo, Inc. New Jersey, United StatesJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
Director Clinical Safety - Basking Ridge, United States - HireTalent
Description
Job Title:
Director Clinical Safety
Job Schedule:
Preference to have a local candidate who is based in tri-state and able to come into the office.
Responsibilities:
Incumbent will be responsible for responses to Health Authority inquiries on safety issues and prepares safety data for health authority review boards
Present safety data in SMTs as a recognized product safety expert and serve as the CSPV functional rep at Global multifunctional project team meetings
This position prepares, summarizes, and reviews aggregate safety analyses
Additionally, this position develops and implements integrated project/product risk management strategies and drafts the Risk Management Plan with Level III
This position performs safety assessments and determines the safety profiles of assigned products
This position also works with other CSPV staff to assess new signals/risks emerging from post marketing data
This position may review and approve safety documents
Provides integrated safety input into all safety relevant parts of regulatory documents (IB, CCDS, RMP, REMS, DSUR, PSUR, SmPC, PI, CSR, Clinical Overview and Integrate safety summary) required during active development, submission phase and during marketing phase
Safety Expert Overall:
Serves as the physician responsible for safety profile and for leading SMTs for post marketing safety data from assigned products
Defines the risk component of the B/R assessment
Safety Expert Signal Evaluation:
Assists manager in assessing signals by surfacing and assembling relevant data and conducting analyses of datasets
Safety Expert Risk Mitigation & Communication: Supports manager in recommending and implementing risk mitigation activities
Proposes risk mitigation solutions to management and SMT
Reports and Submissions:
Contributes to and reviews safety sections of the NDA, CSR, and IB
3-5 years of Pharmacovigilance (PV)/drug safety experience in pharmaceutical drugs either from relevant work experience within the industry or related healthcare work
Demonstrated ability to prioritize work, implement strategy and processes, collaborate with others