Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies.
Develops guidelines and insures the uniform and timely processing of adverse event reports. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Develops and prepares reports for company management as well as external regulatory agencies. Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary.
May work with data management in the ongoing development of case report forms for clinical trials and maintenance of databases.
Performing complete data entry of serious adverse events received from clinical trials, according to the client workflow processes and standard operating procedures.
Generate initial case narratives based on information received as part of source documents including but not limited to, case report forms, hospital admission notes, history and physical (H&P) consult notes, progress notes, lab results, results of diagnostic, radiological and other tests, discharge summaries, death certificate and autopsy results provided by the study sites.
Draft appropriate initial queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior client Drug Safety person.
Communicate or notify client drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines.
Maintain and track all serious adverse events reported from client sponsored clinical trials for case processing relative to their priorities and submission deadlines.
Support Drug Safety Department initiatives on ad hoc (as needed) basis.
Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events.
Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally. Ensure compliance with Client's SOPs.
Experience in oncology therapeutic area is preferred but not mandatory.
Familiarity with Medical terminology required.
Ability to process data entry accurately.
Ability to code and map data accurately.
Concise case narrative (medical) writing experience preferred. Ability to prioritize work without much support.
Clear effective written and verbal communication skills are essential for effective communication with study sites.
Focused and detail oriented.
Work effectively as a team member, promote collaboration.
Self starter and self accountability.
Relevant industry experience is highly preferred.
High level of work conduct