DIRECTOR CLINICAL SAFETY
2 weeks ago
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
-
RN Clinical Director FT
8 hours ago
Sewell, NJ, United States United Surgical Partners International, Inc Full timeSelect Surgical Center at Kennedy has an immediate need for a full time RN Clinical Director!Job Summary: The Clinical Director is responsible for overseeing and developing the ambulatory surgical center’s clinical departments through key tasks such as hiring, evaluating, mentoring, scheduling, and supervision. We seek a professional with proven but...
-
Night RN Telemetry Assistant Director
6 hours ago
Beachwood, NJ, United States Clinical Management Consultants Full timeA prestigious 500 bed hospital nestled in a charming coastal community near central-eastern New Jersey, as a Night RN Telemetry Assistant Director! The Night RN Telemetry Assistant Director will have extensive opportunities for learning and career ad RN, Director, Telemetry, Assistant, Night, Nurse Manager, Healthcare, Staffing
-
Clinical Director
1 week ago
Cleveland, OH, United States Connections In Ohio Full timeConnections in Ohio, Inc. is a growing company that has been providing community supports to individuals with intellectual and developmental disabilities in community settings, for over 26 years. We are seeking a highly organized problem solver for a great opportunity! We are hiring a Clinical Director to support our teams within the areas of all Clinical...
-
Physician Clinic Medical Director
7 days ago
Sarasota, FL, United States Concentra Full timeOverview:Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing exceptional care to our patients. Our mission is to improve the health of America's workforce, one patient at a time. Join us at Concentra and see how your clinical competency and compassion can...
-
Clinical Director
8 hours ago
Lawrenceville, GA, United States Crossroads Hospice Full timeCrossroads Hospice & Palliative Care is interested in meeting with Registered Nurse leaders who are driven to provide the best end-of-life experience to patients and families in our community. Over the last year, we have worked tirelessly to build a core culture of teamwork and compassion.As a Clinical Director for Crossroads Hospice, you oversee all direct...
-
Physician Clinic Medical Director
5 days ago
Chicago, IL, United States Concentra Full timeOverview:Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing exceptional care to our patients. Our mission is to improve the health of America's workforce, one patient at a time. Join us at Concentra and see how your clinical competency and compassion can...
-
Physician Clinic Medical Director
7 days ago
Newport News, VA, United States Concentra Full timeOverview:Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing exceptional care to our patients. Our mission is to improve the health of America's workforce, one patient at a time. Join us at Concentra and see how your clinical competency and compassion can...
-
Clinical Director-RN
2 weeks ago
Princeton, WV, United States PCH Home Health Full timeWe are hiring for a Clinical Director-RN with a minimum of two years Director or above experience in Princeton, West Virginia. At PCH Home Health, a part of LHC Group, we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their families, each other, and the communities we...
-
Physician Clinic Medical Director
6 days ago
Livonia, MI, United States Concentra Full timeAs a Physician Clinic Medical Director at Concentra, you'll spearhead a committed team of clinicians, guaranteeing smooth center operations and delivering unparalleled patient care. Our Medical Directors at Concentra are adept at balancing patient care with recruitment, business metrics, and center operations management. This role seamlessly integrates...
-
Physician Clinic Medical Director
6 days ago
Knoxville, TN, United States Concentra Full timeAs a Physician Clinic Medical Director at Concentra, you'll spearhead a committed team of clinicians, guaranteeing smooth center operations and delivering unparalleled patient care. Our Medical Directors at Concentra are adept at balancing patient care with recruitment, business metrics, and center operations management. This role seamlessly integrates...
-
Director, Quality
3 weeks ago
Tyler, TX, United States UT Health Tyler Full timeOverviewIn a joint venture partnership with UT Health System,Ardent operates UT Health East Texas in Tyler, Texas. UT Health East Texas is comprised of UT Health Tyler (the area’s only Level I trauma center), UT Health North Campus, UT Health Athens, UT Health Carthage, UT Health Henderson, UT Health Jacksonville, UT Health Pittsburg, UT Health Quitman, UT...
-
Director, Quality
4 weeks ago
Tyler, TX, United States UT Health Tyler Full timeOverviewIn a joint venture partnership with UT Health System,Ardent operates UT Health East Texas in Tyler, Texas. UT Health East Texas is comprised of UT Health Tyler (the area’s only Level I trauma center), UT Health North Campus, UT Health Athens, UT Health Carthage, UT Health Henderson, UT Health Jacksonville, UT Health Pittsburg, UT Health Quitman, UT...
-
LABORATORY QA SAFETY COORD-BLOOD BANK
4 weeks ago
Camden, NJ, United States Cooper University Health Care Full timeAbout us At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to our employees by providing...
-
Director, Safety Assurance, Fragrance
1 week ago
Rockleigh, NJ, United States Takasago International Corporation U S A Full timeJob Description:Essential Job Functions:• Responsible for prioritizing workload within the department, triaging time sensitive priorities and ensuring completion of tasks by the department.• Responsible for ensuring that fragrance formulas are evaluated for safety and regulatory compliance according to industry, regulatory and customer requirements.•...
-
Drug Safety Physician
3 weeks ago
Princeton, NJ, United States GForce Life Sciences Full timeThe Project Physician tasks may include:Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical study reports, and other similar documentsContribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or...
-
Clinical Nurse Manager
8 hours ago
Glen Ridge, NJ, United States Healogics, LLC. Full timeThe rewards at Healogics are immense, starting with the important work we do to change patients’ lives. We also understand that meaningful work is hard work, and we are committed to supporting and compensating our employees for the tremendous service they provide.Think you are a great fit? Learn more about this role here:Healogics is the largest provider...
-
Physician Clinic Medical Director
6 days ago
Sterling Heights, MI, United States Concentra Full timeAs a Physician Clinic Medical Director at Concentra, you'll spearhead a committed team of clinicians, guaranteeing smooth center operations and delivering unparalleled patient care. Our Medical Directors at Concentra are adept at balancing patient care with recruitment, business metrics, and center operations management. This role seamlessly integrates...
-
Area Clinical Director Registered Nurse
3 weeks ago
Houston, TX, United States The Pediatric Connection Full timeArea Clinical Director Registered NurseDon't just work, thrive! Thrive SPC, a national provider of Pediatric Private Duty Nursing, is seeking an Area Clinical Director RN to join our team in Houston. We seek a dynamic Clinical Leader who is passionate about improving the lives of the children in the communities we serve. This person would serve as the...
-
LMFT need for Clinical Supervision
8 hours ago
Murrieta, CA, United States TIP OF THE SPEAR CLINICAL THERAPY Full timeBenefits: Competitive salary Flexible schedule Signing bonus Do Not Apply if you do not meet the minimum requirements below, please! Dear Potential Candidate, “Have you gone to multiple therapists who tell you to simply “deep breathe”? Well, that just isn’t enough and oftentimes, offensive. We, at Tip of the Spear,...
-
Registered Nurse
6 hours ago
Oceanport, NJ, United States AcuteCare Health System Full timeBeacon of LIFE - A Program of All-Inclusive Care For The Elderly (PACE). The PACE model is centered on the belief that it is better for the well-being of seniors with chronic care needs and their families to be served at home in their community whenever possible. Currently, we are looking for a Registered Nurse - Clinic to join our Team! Position...