ZipRecruiter

Log In

1

Patient Safety Risk Manager Jobs in Delaware (NOW HIRING)

next page

Showing results 1-20

People also search for

All JobsPatient Safety Risk JobsPatient Safety Risk Manager JobsPatient Safety Risk Manager Jobs in Delaware

Patient Safety Risk Manager information

What are the key skills and qualifications needed to thrive as a Patient Safety Risk Manager, and why are they important?

To thrive as a Patient Safety Risk Manager, you need expertise in healthcare risk management, quality improvement, and a strong understanding of regulatory standards, typically backed by a degree in healthcare administration, nursing, or a related field. Familiarity with incident reporting systems, root cause analysis tools, and relevant certifications such as CPHRM (Certified Professional in Healthcare Risk Management) are often required. Excellent analytical thinking, communication, and leadership skills help in collaborating with multidisciplinary teams and driving safety initiatives. These abilities are crucial for proactively identifying risks, ensuring compliance, and fostering a culture of patient safety within healthcare organizations.

How does a Patient Safety Risk Manager typically collaborate with clinical staff to improve patient safety outcomes?

Patient Safety Risk Managers work closely with clinical teams by facilitating regular safety huddles, reviewing incident reports, and leading root cause analyses when adverse events occur. They serve as a bridge between frontline staff and hospital leadership, offering guidance on best practices and helping to implement policy changes aimed at preventing future errors. This role requires strong communication and relationship-building skills, as effective collaboration is essential for driving a culture of safety and continuous improvement within healthcare settings.

What does a Patient Safety Risk Manager do?

A Patient Safety Risk Manager is responsible for identifying, assessing, and reducing risks to patient safety within a healthcare facility. They investigate incidents, analyze data to spot trends, and develop policies and training to prevent future errors. Their goal is to create a safer environment for patients and staff by promoting best practices and ensuring compliance with healthcare regulations. They also collaborate with medical staff and leadership to implement quality improvement initiatives.

What is the difference between Patient Safety Risk Manager vs Patient Safety Coordinator?

AspectPatient Safety Risk ManagerPatient Safety Coordinator
CertificationsCPPS, CPHRM often preferredCPPS, CPHRM often preferred
Work EnvironmentHealthcare facilities, hospitals, risk management departmentsHealthcare settings, patient safety teams, quality improvement departments
Employer & Industry UsageHospitals, healthcare systems, insurance companiesHospitals, clinics, outpatient centers
Search & Comparison IntentUnderstanding risk management roles in patient safetyAssisting in patient safety initiatives and compliance

The Patient Safety Risk Manager focuses on identifying and mitigating risks to improve patient safety at an organizational level, often handling complex risk assessments and policy development. The Patient Safety Coordinator typically supports these efforts by coordinating safety initiatives, collecting data, and ensuring compliance. Both roles require similar certifications and work in healthcare environments, but the Risk Manager has a broader scope in risk mitigation strategies, while the Coordinator emphasizes operational support.

What are popular job titles related to Patient Safety Risk Manager jobs in Delaware? For Patient Safety Risk Manager jobs in Delaware, the most frequently searched job titles are:
What job categories do people searching Patient Safety Risk Manager jobs in Delaware look for? The top searched job categories for Patient Safety Risk Manager jobs in Delaware are:
What cities in Delaware are hiring for Patient Safety Risk Manager jobs? Cities in Delaware with the most Patient Safety Risk Manager job openings:
Patient Safety Risk Manager jobs near you
Executive Medical Director, Global Risk Management & Safety Surveillance

Executive Medical Director, Global Risk Management & Safety Surveillance

Incyte Corporation

Wilmington, DE

Other

Posted 3 days ago

Job description

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

Job Summary

The Executive Medical Director, Global Risk Management & Safety Surveillance (GRMSS), is responsible for developing and ensuring execution of all patient safety risk management activities for molecular entities under clinical development as well for Incyte marketed products. This will include pharmacovigilance and risk management activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions. The position will require strong oversight for patient safety issues that arise at both the individual and aggregate levels (within the company and in collaboration with co-development and business partners); strong decision-making skills on all issues involving safety assessment and surveillance; responsibility for compliant, timely, and complete regulatory authority engagement (with particular emphasis on benefit-risk assessments and risk identification/characterization and mitigation/management); and effective communication of safety information to internal and external stakeholders. The position will need to effectively lead teams and engage cross-functionally. The Executive Medical Director reports to the Head of Global Pharmacovigilance and Risk Management.

Essential Functions of the Job (Key responsibilities):

  • Lead the Safety Management Team and direct all safety risk management activities for assigned products.
  • Lead other teams, as required.
  • Ensure local and global risk management plan preparation and execution throughout a medicinal product's lifecycle.
  • Formulate clinical trial and postmarketing risk management safety strategies that are in alignment with the company's drug development and commercialization strategies.
  • Perform drug safety signal detection activities for Incyte's portfolio of investigational and marketed products; develop medically reasonable evaluations of safety signals; and make specific, actionable, and defensible recommendations for confirmation or refutation of safety signals.
  • Manage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance.
  • Provide secondary medical review of ICSRs for designated products as necessary as well as back-up when primary medical reviewer is not available, and provide follow-up guidance for specific safety topics to Case Operations team (or PhV vendor as appropriate) to ensure consistent high-quality reports
  • Review emerging literature regarding Incyte products, as well as relevant products from collaboration partners, to identify new and important information that potentially impact human safety; conduct reviews both independently within Incyte and in conjunction with external collaboration partners.
  • Drive preparation of IND Annual Reports and/or DSURs for Incyte clinical trial programs, and PADERs and/or PSUR/PBRERs for marketed products.
  • Perform Health Hazard Evaluations.
  • Participate significantly in the strategic planning, development, and production of integrated summaries of safety, summaries of clinical safety, clinical overviews, and other registration documents for new and supplemental NDAs/BLAs and/or ex-US new drug submissions/variations for late-phase drug development candidates and marketed products in conjunction with Clinical Development, Medical Writing, Statistics, and Regulatory Affairs.
  • Drive the safety strategy for Reference Safety Information for Incyte products, including Investigator Brochures and new or updated labeling (USPI, SmPC or CDS) for marketed products in the context of multidisciplinary groups within Incyte or joint committees between external partners.
  • Participate in internal safety process improvements and updates, including new means of effective presentation of early phase clinical study status reports with regard to safety findings.
  • Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance, and contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific identified deficiencies of policy, procedure, or practice in GRMSS.
  • Review medical and safety content included in standard response letters prepared by Medical Affairs, as necessary, and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information.
  • Champion risk management safety strategy to internal (eg, Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal) and external (eg, regulators and commercial collaborators) stakeholders.
  • Serve as the GRMSS medical representative for joint clinical development programs with external partners as required.
  • In the absence of the EU/UK QPPV, the GRMSS physician (or their back-up) is responsible for responding to product-related queries as delegated by the EU/UK QPPV.

Qualifications:

  • M.D. or international equivalent.
  • Minimum of 10 years of experience in pharmaceutical/biotechnology industry or regulatory agency, of which more than 5 years will have been in a pharmacovigilance or risk management role.
  • In-depth knowledge of US/EU risk management/GVP landscape.
  • First-hand experience interacting with regulators with risk management issues.
  • Experience as an active contributor with drug registrations (Clinical Study Reports, Integrated Summaries of Safety, Summaries of Clinical Safety, and Clinical Overviews).
  • Strong interpersonal and people management skills; experience effectively leading teams.
  • Strong collaboration skills and ability to engage cross functionally.

Preferable (but not an absolute requirement):

  • M.P.H. or relevant epidemiology experience in industry or academia.
  • Board certification in internal medicine or pediatrics (primary care), or hematology/oncology (specialty).
  • Experience in pharmaceutical industry activities outside the United States.
  • Experience in clinical trial development and execution.
  • Training or experience in oncologic or inflammatory diseases, or relating to clinical safety support of oncology, immunomodulatory, or other related products.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

We Respect Your Privacy

Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

#LI-MB1

Apply