Drug Safety Physician
Found in: Careerbuilder One Red US C2 - 1 week ago
The 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 reviewing medical monitoring plans and other plans for clinical trials, internal or between 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
Requirements:
- 3-5 Years experience in Drug Safety with Similar Task
- Experience with single case unblinding
- Knowledge with early development activities and documents (phases 1-2)
- Immunology experience
- Must be an MD or DO
Term & Start
- 12-month contract, open to 12+ month extension
- 2 Video Interviews - Start 2-3 weeks from an offer
- Full time, 40 hours/week
- Hybrid – Onsite 2 days a week onsite (Tuesday and Wednesday)
- Benefits available (Medical, Dental, Vision, 401k)
-
Drug Safety Physician
Found in: Careerbuilder One Red US C2 - 6 days ago
Princeton, NJ, United States GForce Life Sciences Full timePhysician Project Manager, Pharmaceuticals SummaryOur growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Physician Project Manager who will be responsible for Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical...
-
Drug Safety Physician
Found in: Appcast US C2 - 7 days ago
Princeton, United States GForce Life Sciences Full timePhysician Project Manager, Pharmaceuticals SummaryOur growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Physician Project Manager who will be responsible for Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical...
-
Drug Safety Physician
Found in: Appcast Linkedin GBL C2 - 1 week ago
Princeton, United States GForce Life Sciences Full timePhysician Project Manager, Pharmaceuticals SummaryOur growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a Physician Project Manager who will be responsible for Contribute to writing and reviewing of study related documents such as: protocols, protocol amendments, informed consent forms, statistical analysis plans, clinical...
-
DRUG SAFETY PHYSICIAN
Found in: Careerbuilder One Red US C2 - 21 hours ago
, 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...
-
Drug Safety Physician
1 week ago
Princeton, United States GForce Life Sciences Full timeJob DescriptionJob DescriptionThe 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...
-
Drug Safety Physician
Found in: Appcast US C2 - 1 week ago
Princeton, 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...
-
Drug Safety Physician
2 weeks ago
Princeton, 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...
-
Drug Safety Physician
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Princeton, 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...
-
DRUG SAFETY PHYSICIAN
Found in: Careerbuilder One Red US C2 - 20 hours ago
Princeton, NJ 08543, USA, 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...
-
ASSOCIATE DIRECTOR, DRUG SAFETY
Found in: Careerbuilder One Red US C2 - 20 hours ago
Princeton, NJ 08544, USA, United States Sun Pharmaceutical Industries Full timeIND123The Associate Director/ Director, Drug Safety (Title is comensurate with experience) will oversee and implement operations of Pharmacovigilance in North America and communicate relevant information internally and with other members of SUN and its affiliates, including stakeholders as required. The Director will be responsible for ensuring ADE training...
-
Drug Safety Associate
2 weeks ago
Princeton, United States APCER Life Sciences Full timeJob DescriptionJob Description• Book in and Triaging of ICSRs• Perform data Entry of ICSRs in Pharmacovigilance database.• Entering source data in the database, Coding, Narrative(s) writing, and Generate Follow-up letters.• Generation of regulatory/partner submission reports and submission of cases.• Send follow-up/administrative queries.• Review...
-
SR. DRUG SAFETY SPECIALIST, COMPLIANCE
Found in: Careerbuilder One Red US C2 - 21 hours ago
, MD, United States ProClinical Full timeSenior Drug Safety Specialist, Compliance - Contract - Cambridge, MAProclinical is on the lookout for a dedicated and experienced professional to fill the role of Drug Safety and Pharmacovigilance Compliance Specialist. This is a contract position located in Cambridge, MA.Primary Responsibilities:The successful candidate will be instrumental in drug safety...
-
DIRECTOR CLINICAL SAFETY
Found in: Careerbuilder One Red US C2 - 20 hours ago
, NJ, United States HireTalent Full timeJob Title: Director Clinical Safety 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...
-
EXECUTIVE DIRECTOR, DRUG SAFETY AND PHARMACOVIGILANCE
Found in: Careerbuilder One Red US C2 - 22 hours ago
, MA, United States Morphic Holding, Inc. Full timeDescriptionAbout Morphic TherapeuticMorphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery...
-
Safety Manager
15 hours ago
Princeton, United States Calumet Specialty Products Full timeSafety Manager Princeton, LA 71067, USA Req #1556 Friday, April 5, 2024 Who are we? At Calumet we deliver innovative specialty products trusted by companies across the globe. We are the foundation to everyday essential products that help millions of people live and thrive. We are headquartered in Indianapolis and have numerous production locations in the US....
-
DRUG SCREEN TECHNICIAN
Found in: Careerbuilder One Red US C2 - 24 hours ago
, VA, United States Bayview Physicians Group Full timeBayview Physicians Group, is a rapidly growing outpatient multi-specialty medical group that strongly believes the doctor-patient relationship is the cornerstone of quality healthcare. We staff more than 900 positions in the Hampton Roads area, and are always taking applications for new positions. Individuals who possess excellent customer service skills,...
-
Senior Manager, Safety Operations
1 week ago
Princeton, United States CareerBuilder Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com . Senior Manager, Safety Operations & DM page is loaded Senior Manager, Safety Operations & DM Apply locations Japan time type Full time posted on Posted 30+ Days Ago job...
-
DRUG TESTING PROGRAM COLLECTOR
Found in: Careerbuilder One Red US C2 - 24 hours ago
, CT, United States Dattco Full timeDATTCO is currently hiring a full-time Drug Testing Program Collector for our Safety Department in New Britain, CT.DATTCO is a third-generation, family-owned company and is the largest private passenger transportation company in New England. Learn more about us at
-
LICENSED CLINICAL ALCOHOL AND DRUG COUNSELOR
Found in: Careerbuilder One Red US C2 - 22 hours ago
, NJ, United States Newbridge Health & Wellness Full timeSupervises staff and provides addiction treatment services to chemically dependent patients by conducting intake screenings, assessments and makes recommendations for further diagnostic evaluations as a leader of a multidisciplinary team. Demonstrates as role model for and to staff in assisting with ongoing education, training, and professional...
-
PATIENT SAFETY COORDINATOR
Found in: Careerbuilder One Red US C2 - 2 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 its employees by providing...