RESPONSIBILITIES
- 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 Sponsor and 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 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
EXPERIENCE
- 3-5 Years experience within Drug Safety
EDUCATION
- MD (Doctor of Medicine) or DO (Doctorate of Osteopathic Medicine) required
