Drug Safety Physician

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)