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Healthcare Associate Medical Safety Director

Medical safety director oversees adverse event review, pharmacovigilance, and regulatory safety documentation for pharmaceutical products in clinical trials and post-market surveillance.

Senior Remote Posted about 16 hours ago Himalayas
What this role involves
Job Title: Associate Medical Safety Director Job Location: Tokyo, Japan Job Location Type: Home-based Job Contract Type: Full time Job Seniority Level: Grade:160【部署】Safety 部門日本拠点のMDは現在4名。現在増員でもう1名募集中。このポジションは日本のチームをまとめていただくリーダーポジションです。レポートはグローバルになります。 (日本語)• 治験または市販後、安全性に関する医学的アドバイス • 有害事象・副作用入力情報を見て新規・既知の判断や、追加収集情報の依頼 • 文献評価のサポートなど医学的アドバイス • 研究措置報告の評価 領域としては、メジャーな低分子医薬品よりも抗体医薬・生物製剤が多くを占め、オンコロジーやオーファン領域のプロジェクトが多い 【必須要件】• 日本の医師免許(履歴書に忘れずに記載ください) • 企業経験は必須としていないが、リモート環境でも柔軟に対応できる、適応能力は必要です • リーダーシップ、マネジメントスキル • 英語力:ビジネスレベル • 日本語力:ビジネスレベル以上、十分にステークホルダーとコミュニケーションが取れるレベル 【尚可】CROやメーカーで経験のある先生(安全性の経験は必須ではない) 企業経験(English ) Essential Functions• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary • Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements • Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported • Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile • Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data • Represent safety and clinical data review findings during client meetings • Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports • Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies • Provide medical oversight for label development, review and change • Provide medical support and attendance at Data Safety Monitoring Board Meetings • Attends and contributes medical safety evaluation on Safety Monitoring Committees • Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document • Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments • Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract • Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture.
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Healthcare $100k starting bonus with up $56 WRVU ED Overnight Teleradiology 10 and 8 hour options

Emergency radiologist interprets diagnostic imaging studies (X-ray, CT, MRI) for acutely ill patients on overnight shifts with flexible 8-10 hour shift options.

Senior Remote Posted about 23 hours ago RemoteOK Dev
What this role involves
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$100k starting bonus with up to $56 WRVU ED Overnight Teleradiology Remote, 10- and 8-hour options

Orlando Health Medical Group

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Details

Posted: 08-Jun-26

Location: Orlando, Florida

Type: Full Time

Subspecialties

Diagnostic Radiology

Emergency Radiology

Interventional Radiology

Musculoskeletal Radiology

Neuroradiology

Non-Specialty Specific

Nuclear Medicine

Additional Information

Hybrid/Remote is allowed.

7 on/14 off Remote Overnight Emergency Imaging Radiologist with Orlando Health, Nationally Ranked Hospital

Orlando Health Medical Group is seeking well-trained and motivated radiologists to provide overnight Emergency imaging coverage. The ideal candidate is comfortable with all modalities of general body imaging and stroke imaging including CTA and CTP. Our Emergency Radiologists oversee all aspects of diagnostic imaging for acutely ill and injured patients. Our imaging spans all organ systems and modalities including X-ray, CT, and MRI. Candidates must have a demonstrated career interest in Emergency Radiology with excellent clinical skills in all modalities and organ systems. Neuroradiology expertise is highly regarded but not required. This position works closely with a team of experienced radiologists equally sharing the work covering STAT exams and non-subspecialty routine studies with opportunity to participate in clinical research and resident education. Prior experience in Emergency Radiology is preferred. Candidate must be able to thrive in 7 on, and 14 off overnight schedule.

Candidate Should Expect

  • Candidates can choose between doing 10- or 8-hour shifts
  • Extremely competitive base compensation with a $56 WRVU
  • $100k starting bonus
  • Working within an all-inclusive, high-volume group
  • Utilizing the Epic© comprehensive health record keeping system
  • Phillips PACS system
  • CT, MRI, Body Imaging, Emergency Radiology, Neuroradiology, General Radiology
  • Not a J-1 visa sponsored position.

Orlando Health Medical Group performs over 3 million encounters annually across more than 200 ambulatory locations. The facilities our Medical Group serves includes including Orlando Regional Medical Center, a Level I trauma center, Arnold Palmer Hospital for Children, Winnie Palmer Hospital for Women & Babies, Orlando Health Cancer Institute, Dr. P. Phillips Hospital, South Seminole Hospital, South Lake Hospital, St. Cloud Regional Medical Center, Orlando Health’s Health Central Hospital and Bayfront Health Hospital. Additionally, our group proudly serves several free-standing ERs and outpatient imaging centers.

Role Requirements

  • BE/BC by the American Board of Radiology or the American Osteopathic Association.
  • Fellowship training is preferred but not required.
  • Successful completion of an ACGME/AOA accredited training program in Radiology.
  • Unrestricted Florida medical license (or the ability to obtain one).
  • Not a J-1 visa sponsored position.

Benefits Package

  • Competitive compensation package
  • General radiology moonlighting available with weekend and evening shifts
  • Benefits package includes health/vision/dental insurance, along with full malpractice coverage, disability coverage, deferred compensation and 403(b) with employer match
  • Generous starting bonus with eligibility for an annual bonus
  • CME Stipend
  • Eligible employer under the Public Student Loan Forgiveness Program

Orlando Community

  • No state income tax for Florida residents!
  • Greater Orlando offers direct access to Florida’s world-famous theme parks and attractions.
  • Our lifestyle options have something for everyone, from the downtown districts for those enjoying a trendy urban flair, to family-oriented communities with top-rated public and private schools.
  • We have ample outdoor activities including large public parks for your kids and pets, hiking and biking trails, abundant lake access for kayaking, fishing and paddle boarding, with Florida’s beautiful beaches only an hour away.

Orlando Health Medical Group Radiology

With the 2022 acquisition of Medical Center Radiology Group (MCRG), whose board-certified radiologists have interpreted medical imaging for the healthcare system since 1949, Orlando Health is further leveraging the expertise of the radiology group and supporting an ongoing investment in patient care. Orlando Health Medical Group Radiology is the diagnostic radiology, interventional radiology and nuclear medicine group for all Orlando Health hospitals as well as the system’s numerous freestanding ERs and Orlando Health Imaging Centers outpatient locations throughout Central Florida, with many modalities accredited by the American College of Radiology. Radiology services offered include:

  • CT/MRI
  • Interventional Radiology
  • Musculoskeletal Imaging
  • Neuroradiology
  • Oncology Imaging
  • Pediatric Radiology
  • Radiography and Fluoroscopy
  • Trauma and Emergency Medicine
  • Women’s Imaging

Facility & Address

  • Orlando Health Medical Group Radiology
  • 52 W Underwood Street Orlando FL 32806

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About Orlando Health Medical Group

Orlando Health is a not-for-profit healthcare organization with $7.6 billion of assets under management that serves the southeastern United States. Headquartered in Orlando, Florida, the system was founded more than 100 years ago.

Connections working at Orlando Health Medical Group

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Healthcare Lead Clinical Research Associate at PSI CRO

Lead Clinical Research Associate oversees clinical trial monitoring, manages regional research teams, ensures protocol compliance, and coordinates study quality across multiple sites with minimal travel.

Lead Remote Posted 2 days ago RemoteFirstJobs Product
What this role involves

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality.

  • Coordinates investigator/ site feasibility and identification process, as well as study startup.
  • Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
  • Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
  • Manages Monitors in the query resolution process, including Central Monitoring observations.
  • Coordinates safety information flow and protocol/process deviation reporting.
  • Performs clinical supplies management with vendors on a country and regional level.
  • Ensures study-specific and corporate tracking systems are updated in a timely manner.
  • Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
  • Coordinates planning of supervised monitoring visits and conducts the visits.
  • Manages the project team in site contracting and payments.
  • Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
  • Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
  • Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
  • Oversees project team in CAPA development and implementation.
  • Coordinates project team in process deviations review, management and reporting.
  • Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
  • Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
  • Delivers trainings and presentations at Investigator Meetings.
  • Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
  • Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
  • Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
  • Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
  • Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
  • Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
  • Ensures data integrity and compliance at a site level.
  • Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
  • Conducts project-specific training of site Investigators.
  • Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

  • Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
  • Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
  • Must have prior experience monitoring or managing sites and CRAs in the United States with knowledge of US regulatory guidelines and practices.
  • Experience with all types of monitoring visits in Phases I-III.
  • Strong experience in Oncology preferred.
  • Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.
  • Strong experience in GI (Chron’s, Ulcerative Colitis, IBS) preferred.
  • Full working proficiency in English.
  • Proficiency in MS Office applications.
  • Ability to plan, multitask and work in a dynamic team environment.
  • Excellent Communication, collaboration, and problem-solving skills.
  • Ability to travel up to 65% (depending on project needs).
  • Valid driver’s license (if applicable).

Additional Information

All your information will be kept confidential according to EEO guidelines.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Read the full description
Healthcare Lead Clinical Research Associate at PSI CRO

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Lead Remote Posted 2 days ago RemoteFirstJobs Product
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Job Description

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  • Coordinates planning of supervised monitoring visits and conducts the visits.
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For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Read the full description
Healthcare Medical Assistant - Virtual Cardiac Rehab (RPM/CCM) at Movn Health

Medical assistant monitors cardiac patients' remote vitals, logs billable care coordination time, moderates virtual exercise classes, and manages clinical workflows in an EHR system.

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Medical Assistant – Cardiac Care Management

Full-Time | Remote | Clinical Operations

About Movn Health

Movn Health is redefining how people recover from heart disease. As the nation’s leading virtual cardiac rehabilitation and cardiovascular care provider, our mission is to help every person live a longer, stronger, and more confident life after a heart event. Developed in collaboration with Stanford University and grounded in decades of published clinical research, Movn delivers a recovery experience that is personalized, compassionate, and proven to improve outcomes. Our fully virtual program makes world-class cardiac rehab accessible from home — helping patients build lasting heart-healthy habits while reducing hospital readmissions and costs for our partners. At Movn Health, we believe heart care should be human, proactive, and accessible to everyone — and we’re building the future of cardiac recovery to make that vision real.

The Role

We’re looking for a Medical Assistant with a clinical eye, a bias for action, and a genuine interest in cardiac care. You’ll be embedded in our care delivery team — monitoring patient vitals daily, logging CCM time, managing our RPM practice and supporting our virtual cardiac exercise program, and keeping the clinical operation running cleanly in eClinicalWorks. This is a hands-on remote role with real clinical weight and room to grow.

What You’ll Own

RPM & CCM Monitoring

- Review the RPM vitals dashboard daily; identify and act on abnormal BP, heart rate, weight changes, and missed readings

- Initiate timely patient outreach for abnormal vitals (text first, phone follow-up by end of day) and escalate urgent concerns to the care manager

- Log asynchronous CCM time in eCW for billable care coordination activities: chart prep, post-visit follow-up, medication reconciliation, care plan updates, and provider coordination

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Virtual Cardiac Exercise Program

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- 2+ years of MA experience in a clinical, telehealth, or care management setting

- eClinicalWorks (eCW) proficiency — this is our system of record for all documentation, CCM time logging, and care plan management; prior experience is required

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- Experience in cardiology, cardiac rehab, or a cardiac-focused telehealth setting is a strong plus

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- Bilingual a plus

Who You Are

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- You don’t need to be managed; you manage yourself and your panel

- You care about patients, not just tasks — and it shows in how you communicate

- You’re comfortable in a fast-moving, fully remote environment and know how to stay organized without someone looking over your shoulder

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- Health, dental, and vision benefits

- Paid time off and company holidays

- Mission-driven team working at the intersection of cardiac care and technology

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Job Description

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Home-Based in Mexico

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Qualifications

  • Medical Doctor degree required
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  • Proficiency with MS Office applications
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  • Problem-solving, team and detail-oriented

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