Medical Director, Safety Risk Management
Scorpion Therapeutics
Who You Are Medical Director, Safety Risk Management provides pharmacovigilance, regulatory, and medical expertise for assigned United Therapeutics product(s)/program(s) across lifecycle; supports safety/pharmacovigilance deliverables to ensure favorable benefit-risk balance and business operations. Responsibilities Medically/clinically support drug safety/pharmacovigilance deliverables (e.g., ICSR medical review, aggregate reports/line listing, RSI (dCSI/CCSI & IB), NDA/BLA/IDE/PMA submission, dRMP/RMP, REMS, safety variations, routine/ad-hoc signal detection, regulatory questions) Update Benefits:Risk (B:R) Assessment; review blinded clinical trial data Perform ICSR medical review/assessment for product assignment; spot-check CRO medics for consistency/trends Review/document safety findings; analyze listings to identify safety trends/signals Write HHE for quality issues/patient impact; support FMEA and MDR determination (drug-device combination or device) Lead safety discussions with DMC/DSMB; review/input study protocols and safety-impact documents (CIBs, ICFs, IB, COR) Collaborate with investigators and medical monitors on emerging safety issues and mitigation Lead/write regulatory authority safety responses; support MARC/ISS/PAP/EAP activities Lead/plan observational studies using safety data; train CRO/teams; serve as medical expert as needed Minimum Requirements MD 5+ years patient safety experience; 5+ years clinical practice; 3+ years international pharma industry experience (clinical research, drug safety, medical affairs, medical monitoring) Data analysis ability; strong oral/written communication; interpersonal/time management Independent, reasoned problem-solving; flexibility; cross-functional relationship building; self-starter Preferred Qualifications 5+ years pharma/R&D/clinical studies or PI experience; 2+ years matrix experience; 5+ years ICSR review/interpretation MD with state physician licensure Ability to influence stakeholders and meet regulatory/safety/business objectives Benefits Medical/dental/vision/prescription; wellness resources; 401k/ESPP; paid time off and paid parental leave; disability benefits. Job Location Durham, NC (hybrid: 3 days in office; 2 days/week remote); travel up to 10%; relocation assistance may be available. #J-18808-Ljbffr Scorpion Therapeutics
- Scorpion Therapeutics in Chapel Hill, NC, is looking for a Medical Director for Safety Risk Management. This role requires expertise in pharmacovigilance, regulatory matters, and clinical safety across product lifecycles. Key responsibilities include supporting drug safety...SuggestedWork at officeRemote work
- ...Reporting to the Vice President of Risk Management, the Director of Risk Management assists the Vice President... ...the day to day operations of UNC Medical Center's, UNC Liability Insurance... ...with the objective of promoting patient safety and loss prevention activity in...SuggestedFull timeWork at officeLocal area3 days per week
UNC Health
Chapel Hill, NC1 day ago - Duke Health in Durham, NC is seeking a professional to manage liability investigations and risk assessments. The ideal candidate will have a Bachelor's degree in a relevant field, a minimum of four years of experience in patient care or health care administration, and...Suggested
- Duke PF in Durham, North Carolina, is seeking a Risk Manager to oversee investigational and liability activities. The candidate must have... ...position requires strong interviewing and investigation skills, as well as familiarity with medical terminology. #J-18808-Ljbffr Duke PFSuggested
- Population Health Care Manager - Rising Risk Location: Durham, NC, US, 27710 Requisition Number: 270629 Regular or Temporary: Regular Job Level... ...frequent hospital and emergency department utilization, and medical, behavioral health, and psychosocial needs by performing...SuggestedTemporary work
- Duke Health is seeking an Insurance Manager to provide essential support for the Clinical Risk Management Department. This role involves developing insurance programs... ...for effective program support. Generous PTO and medical benefits are offered, alongside relocation...Relocation package
- Population Health Care Manager Team Lead Rising Risk Requisition Number: 271907 | Regular | Location: Durham, NC, 27710 Duke Connected Care , a... ...a small caseload, completing documentation, assessment, medication reconciliation, and care planning within required timeframes...
- ...patients in Durham and surrounding areas. Population Health Care Management Team Lead The Care Management Team Lead works in coordination... ...meeting required timeframes for documentation, assessment, medication reconciliation, and care planning. Required Qualifications at...
- ...Site Director Of Clinical Risk Management At Duke Health, we're driven by a commitment to compassionate care... ...and partners closely with Patient Safety, Regulatory, Compliance, Legal Counsel... ...risk management information to Medical Staff Services to support credentialing...Local areaImmediate start
- ...comprehensive anatomic and clinical pathology services and serve as Medical Director of the laboratory at a UNC Health hospital. This position is... .... Provide oversight of laboratory quality, patient safety, and regulatory compliance, including CLIA, CAP, and other accrediting...Full timeLocal areaRelocation package
- ...Summary Initiate, coordinate, and manage all investigational and... ...resolution with the authority from the Director. Provide basic and complex preventive risk management assessment of processes... ...Interviewing Skills Investigation Skills Medical Terminology Analyze Data Analyze...
Duke PF
Durham, NC4 days ago $98.2k - $273.2k
## Associate Director Safety Project LeadershipApplylocations: Durham, North... ..., as assigned by senior management team. Act as Sponsor's primary... ...or project, and potential risks, associated mitigation and support... ...(Pharmacovigilance, CEVA, Medical Information, Safety...Full timeContract workPart timeLocal areaImmediate startWorldwide- Duke Health is looking for an Insurance Manager to lead the clinical risk management efforts. The role includes managing professional liability insurance programs, evaluating risk financing trends, and providing consultation on insurance issues. Candidates should have a...Relocation package
- A prominent health institution in Durham, NC, is seeking an Insurance Manager to provide support to its Clinical Risk Management Department. This role, which offers a hybrid work arrangement, encompasses various responsibilities including evaluating risks, managing insurance...
- ...dedicated professional to supervise the Nutrition and Food department in Chapel Hill. This role includes overseeing food services, managing staff, and ensuring all operational standards are met. The ideal candidate must have at least a high school diploma and two years...Hourly payFull time
- Duke Clinical Research Institute is seeking an Insurance Manager to oversee the professional liability insurance program. Responsibilities include providing administrative support to the Clinical Risk Management Department, evaluating insurance policies, and advising on...
- United Therapeutics Corporation seeks an Associate Clinical Safety Surveillance Director to oversee the management of adverse events in clinical trials. This role requires significant experience in pharmacovigilance and entails developing procedural documents and best...
- ...Belcan is seeking a Clinical Study Manager/Clinical Trial Manager in the United States to oversee day-to-day management of clinical studies... ...in clinical reseach are preferred. Responsibilities include risk management, vendor oversight, TMF/CTMS/EDC familiarity, and driving...
Belcan
Durham, NC10 hours ago $114.1k - $211.9k
Job Description Summary The Manager, Health, Safety and Environment, is responsible for supporting the expansion of Durham campus operations to... ...Serve as a trusted HSE advisor, providing expert guidance on risk management, regulatory compliance, and transparent reporting...For contractors- UNC Health is seeking a Pathology Medical Director to provide comprehensive services at the UNC Medical Center in Chapel Hill, NC. The ideal candidate will focus on operational excellence and regulatory compliance, ensuring timely pathology services. This role emphasizes...
- ## Associate Clinical Safety Surveillance DirectorApplyremote... ...Safety Surveillance Director plays a key role in management and oversight of SAEs and... ...proper management of benefit/risk of UTC developmental products... ...including data entry, QC, medical review, regulatory...Work at officeLocal area3 days per week
- ...issues today and address the medical challenges of tomorrow. We strive... ...new role, the Associate Director of EHS - Strategic Projects will... ...environmental Impacts Safety by Design - Anticipate and eliminate... ...for various levels of management and ensure the implementation...Full timeTemporary workFor contractorsWork experience placementLocal area
- Advanced Group is seeking a Contract Clinical Study Manager to provide leadership across studies from start-up to close-out. The role collaborates... ...combines extensive trial operations expertise with strong risk management and cross-functional teamwork, ensuring inspection...Contract work
- ...Client just minutes outside of Durham, NC is looking for a Medical Director that is a board certified psychiatrist to oversee operations for multiple facilities. Position comes with Competitive Salary, Benefits, CME, and PTO. Must have active NC license and prior leadership...
Cambridge Medical Professionals
Durham, NC3 days ago - ...Risk Management Director Lincoln Community Health Center, Inc., a federally qualified health center serving the Durham County community for... ...Program to include training activities, promoting health and safety to all employees by facilitating the Employee Health...
$248k - $298k
...National Services (VOANS) is seeking a Medical Director . The Medical Director Provide... ...providers. In conjunction with Contract Manager engages in communication with the provider... ...practice is in compliance with Occupational Safety and Health Administration (OSHA)...Contract workTemporary workMonday to FridayWeekend workVOANS, Senior Community Care of NC
Durham, NC1 day ago$111.2k - $309.8k
...Director, Data Sciences, Safety and Regulatory, FSP Sales Director, Data Sciences, Safety and Regulatory, FSP Sales will contribute... ...Sales organization - FSP services for the Data Management, Biostatistics, Programming, Medical Writing, Lifecycle Safety, and Regulatory...Full timeContract workPart timeBank staffWorldwideIQVIA
Durham, NC5 days ago$220k - $245k
...Services (CPS) business unit, ensuring a robust, risk-based, and inspection-ready quality management system aligned with global regulatory expectations... ...Ensure alignment with Clinical Operations, Medical, and Safety Embed quality-by-design principles into early-phase...Full timePart timeFlexible hours$35.87 - $51.57 per hour
...specialist role. You will lead trauma process improvement initiatives and collaborate with multidisciplinary teams to enhance patient safety and outcomes. This role demands a Bachelor of Science in Nursing and a Registered Nurse license in North Carolina, along with three...Hourly payFlexible hours- ...Medical Director Detention Center The Medical Director Detention Center... ..., reviews complex or high-risk clinical cases, and directly... ...spent working in this position. Management may assign additional... ...Durham County. Essential Safety Functions: ~ It is the responsibility...Contract workImmediate startNight shiftWeekend work
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