- 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 documents -Experience with single case unblinding -Knowledge with early development activities and documents
- Contribute to writing and reviewing medical monitoring plans and other plans for clinical trials, internal or between Otsuka Pharmaceutical Development & Commercialization, Inc. and a CRO
- Serve as the primary medical contact for assigned trial.
- Provide oversight of medical monitoring activities and medical surveillance activities of CRO
- Participate in the evaluation and oversight of clinical trial safety surveillance activities
- Contributes to the review of draft and final clinical trial tables and listings
- Contributes to the review of draft and final clinical study reports
- Participates in the analysis of study data and in post-hoc analyses
- Participates and contributes to the designated product Safety Governance meetings and other routine interactions with OPDC Pharmacovigilance
- Reviews and contributes to product-wide aggregate report documents, e.g., IB, DSUR, PSURs, annual reports and other similar documents as assigned
- Performs signaling activities including review of medical/scientific literature, and contribute to safety surveillance process, including the identification of safety observations, emergent safety concerns and new safety signals, and ensure prompt assessment and communication of confirmed safety signals
- Active contribution to internal and external forums (e.g., DMC, Advisory Boards)
- Develops and implement Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS)
- Contributes to product label development, scientific regulatory responses, coding review and approval.
- Contributes to oversight and provides guidance to medical review of individual case safety reports (ICSRs) for investigational and marketed products
- Contributes to scientific and medical publications, posters and presentations as needed
- 3-5 Years experience in Drug Safety with Similar Task
- Must be an MD or DO
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Drug Safety Physician
4 weeks ago
GForce Life Sciences Princeton, United StatesThe 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 documents · Contribute to writing and r ...
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Drug Safety Physician
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GForce Life Sciences Princeton, NJ, United StatesThe 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 documents · Contribute to writing and r ...
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Drug Safety Physician
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GForce Life Sciences Princeton, United StatesThe 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 documents · Contribute to writing and revi ...
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ADC Therapeutics SA New Providence, United StatesApply · Job Type · Full-time · Description · Global Safety Physician · New Providence, NJ/Hybrid/Remote · Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people ...
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Johnson & Johnson Horsham, United States· Johnson & Johnson, is recruiting for a Director, Safety Surveillance Physician (Oncology) to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA. · At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld w ...
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Director, Safety Surveillance Physician
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Johnson & Johnson Horsham, United StatesJohnson & Johnson, is recruiting for a **Director, Safety Surveillance Physician (Oncology) **to be located in Titusville, NJ; Raritan, NJ; or Horsham, PA. · We are Johnson & Johnson. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of ...
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Director, Global Drug Safety
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Genmab A/S Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Associate Director, Global Drug Safety
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Genmab Princeton, United StatesAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
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Goldwater Care Princeton Princeton, United StatesWe have full-time and part-time positions available · SUMMARY: The LPN is responsible for providing direct nursing care to the residents, and to supervise the day-to-day nursing activities performed by nursing assistants. Such supervision must be in accordance with current federa ...
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Nurse Practitioner
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Premise Health Princeton, United StatesResponsibilities · Healthcare Without RivalPremise Health is the world's leading direct healthcare provider and one of the largest digital providers in the country, serving over 11 million eligible lives across more than 2,500 of the largest commercial and municipal employers i ...
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Registered Nurse
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Premise Health Princeton, United StatesEssential Functions Uses nursing skills to evaluate patient care needs, prioritize treatment, and maintain patient flow. Conducts a nursing assessment by taking a patient history and physical assessment and by obtaining vital signs and other medical tests. Provides treatment wit ...
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Home Health Aide CAH
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Deaconess Health System Princeton, United States Supplemental - VariousSummary · Home Health Aide CAH · Functions as a patient advocate by communicating to the responsible nurse observations made while providing patient care; requests from family / patient etc. · Shows genuine concern to all patients, physicians, and customers; acknowledges all cu ...
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The Hun School of Princeton Princeton, United StatesThe Hun School of Princeton seeks a dynamic and creative Weekend Per Diem Nurses. The Weekend Per Diem Nurses will work 12-hour shifts and report to the Director of Health Services and are responsible for personally providing exceptional medical care to our students. · Nursing Re ...
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MRI Lead technologist
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OB/GYN Hospitalist Position, sign-on bonus
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TeamHealth Princeton, NJ, United StatesLooking for an opportunity to work alongside an esteemed group of OB/Gyn physicians? Join TeamHealth's OB/Gyn hospitalist program at Penn Medicine's Princeton Medical Center located in central New Jersey. Princeton Medical Center is affiliated with the University of Pennsylvania ...
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OB/Gyn Hospitalist in Princeton, NJ
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TeamHealth Princeton, NJ, United StatesLooking for an opportunity to work alongside an esteemed group of OB/Gyn physicians? Join TeamHealth's OB/Gyn hospitalist program at Penn Medicine's Princeton Medical Center located in central New Jersey. Princeton Medical Center is affiliated with the University of Pennsylvania ...
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TeamHealth Princeton, NJ, United StatesTeamHealth is looking for an exceptional OB/GYN physician committed to delivering compassionate high-quality patient care to lead our team at Penn Medicine Princeton Medical Center. Princeton Medical Center is affiliated with the University of Pennsylvania Health System which all ...
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Drug Safety Physician - Princeton, United States - Clinical Resource Network (CRN)
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Description
Our client is looking to fill the role of Drug Safety Physician. This role will be hybrid and based out of the Princeton office.
Responsibilities:
Required Qualifications:
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
