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Clinical Risk Manager Jobs in Springfield, PA (NOW HIRING)

ParetoHealth

Senior Underwriter - New Business

Philadelphia, PA · Hybrid

$99K - $117K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

This role is pivotal in assessing and managing the risks associated with self-funded health plans ... clinical risk team * Ensure adherence to industry standards and legal requirements in all ...

Jj

Manager, Clinical Data Management

Spring House, PA · On-site +1

  • Retirement

  • PTO

Clinical Data Management Job Category: Professional All Job Posting Locations: Horsham ... Advanced project and risk management skills with an established track record delivering successful ...

Jj

Manager, Clinical Data Management

Horsham, PA · On-site +1

  • Retirement

  • PTO

Clinical Data Management Job Category: Professional All Job Posting Locations: Horsham ... Advanced project and risk management skills with an established track record delivering successful ...

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Clinical Risk Manager information

What are the key skills and qualifications needed to thrive as a clinical risk manager?

To thrive as a Clinical Risk Manager, you need a solid background in healthcare, risk management, and regulatory compliance, typically supported by a clinical degree and certifications such as CPHRM (Certified Professional in Healthcare Risk Management). Familiarity with incident reporting systems, electronic health records, and risk analysis tools is essential. Strong analytical thinking, communication, and problem-solving skills enable effective collaboration with healthcare teams and leadership. These competencies are vital for identifying, mitigating, and preventing risks to ensure patient safety and regulatory compliance in healthcare organizations.

How does a clinical risk manager collaborate with clinical staff to improve patient safety?

Clinical Risk Managers work closely with nurses, physicians, and other healthcare professionals to identify potential risks and prevent adverse events. They often conduct root cause analyses after incidents, facilitate safety training sessions, and lead multidisciplinary meetings to discuss risk mitigation strategies. By fostering open communication and encouraging reporting of near-misses, they help create a culture of safety and continuous improvement within the healthcare facility.

What is the difference between Clinical Risk Manager vs Clinical Risk Coordinator?

AspectClinical Risk ManagerClinical Risk Coordinator
CertificationsCPHRM, RACCPHRM, RAC (sometimes)
Work EnvironmentHospitals, healthcare organizations, risk management departmentsClinics, healthcare facilities, risk management teams
ResponsibilitiesOversees risk management programs, develops policies, analyzes risksAssists in risk assessments, supports risk mitigation efforts, data collection

The Clinical Risk Manager typically holds more advanced certifications and has broader responsibilities in developing and overseeing risk management strategies. The Clinical Risk Coordinator supports these efforts through data collection and risk assessment assistance. Both roles are essential in healthcare risk management but differ in scope and seniority.

Is healthcare risk management a good career?

Healthcare risk management is a growing field that involves identifying and reducing risks to improve patient safety and compliance. Clinical risk managers typically need strong analytical skills, knowledge of healthcare regulations, and certifications such as Certified Professional in Healthcare Risk Management (CPHRM). It offers opportunities for advancement and a stable career in the healthcare industry.

What do clinical risk managers do?

Clinical risk managers identify, assess, and develop strategies to reduce risks related to patient safety and healthcare quality. They analyze incident reports, implement safety protocols, and ensure compliance with healthcare regulations, often using data analysis tools. Their role helps prevent errors and improve overall clinical outcomes.

What job categories do people searching Clinical Risk Manager jobs in Springfield, PA look for?

The top searched job categories for Clinical Risk Manager jobs in Springfield, PA are:

What cities near Springfield, PA are hiring for Clinical Risk Manager jobs?

Cities near Springfield, PA with the most Clinical Risk Manager job openings:

Clinical Risk Manager jobs near you

Senior Medical Director - Executive Medical Director, Global Risk Management & Safety Surveillance

Incyte Corporation

Wilmington, DE • On-site

Full-time

Re-posted 4 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 Senior Medical Director - 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:
  • 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 (Minimal acceptable level of education, work experience, and competency)
  • M.D. or international equivalent.
  • Minimum of 10 years total pharmaceutical/biotechnology industry or regulatory agency experience, of which more than 5-10 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.
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