Essential Job Functions:
- Oversee, process/review/evaluate, and track adverse events
- Manage timelines and deliverables for safety team/Clinical Safety Specialists
- Coordinate safety-related regulatory reporting to global health authorities; manage the interaction between Clinical Safety Specialists with Regulatory Affairs and Clinical Operations to ensure timely reporting of AEs, SAEs and UADE’s, including expedited and safety input into the annual reporting and other documents as needed
- Manage and oversee the overall process for additional safety-related tasks (aggregate trend review and signal detection)
- Ensure consistency and regulatory compliance in adverse event definitions, adjudications and coding across all clinical programs
- Train internal and external contacts on safety-related matters
- Participate/assist in identifying and engaging academic based medical experts for participation on CEC panels, or working with CROs who oversee this function, as applicable
- Responsible for the development and maintenance of all technical systems utilized in the conduct of clinical event identification, management and adjudication as well as systems used to manage and document all serious adverse events (SAEs).
- Oversee the development and implementation of safety program initiatives, process improvements, and sound safety principles and practices.
- RN or equivalent healthcaredegree at the bachelor’s degree or greater
- At least 8years of clinical research safety experience, including clinical safety events management
- 3+ years of experience managing personnel is preferred
- Working knowledge of the pharmaceutical, biotechnology and/or medical device clinical trial data management and processes, including the regulatory requirements of 21 CFR Part 11, ICH-GCP, other relevant Guidance documents (ICH, FDA, EMA etc.).
Additional Desirable Qualifications Skills and Knowledge:
- Experience in cardiovascular and/or peripheral vascular field
- Prior project management experience is preferred
- Proven facilitation skills and the ability to arrive at consensus among competing stakeholders. Must be a leader but still a team player
- Familiarity with multiple EDC systems
- Knowledge and working familiarity of MedRA coding and safety management systems (eg. AERS, ARGUS)