- 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
- 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
- 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)
- Salary: K
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Drug Safety Physician - Princeton, United States - GForce Life Sciences
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