Contributes to full life cycle of safety data retrieval activities data query, authoring, validation and publishing reports.
Executes validation protocols.
Demonstrates attention to detail, teamwork and initiative.
Understands relational databases and reporting tools.
Sets work priorities and direction with input from manager.
Knowledge of computer systems, data processing, and enterprise software applications.
Technical experience with computer systems, databases, and end user support.
Good working knowledge skills with Microsoft Office Products, Microsoft Visio, and Microsoft Project.
Understands current regulations within drug safety.
Operations Sets work priorities and direction with input from Manager.
Review, extract and accurately enter AE data from ICSR reports from both investigational and post marketing products.
Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete narrative summaries.
Performs review of ancillary documentation accompanying ICSR reports and identifies pertinent information for incorporations into the case narrative.
Correctly identify cases requiring targeted follow-up, determine relevant follow-up required and prepare follow-up queries.
Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate.
Will interact with other Drug Safety functional areas to process adverse events efficiently and reliably.
Will liaise with clinical department, affiliate, marketing or contract research organizations as needed on safety data issues (i.e., obtaining clarification or follow-up information).
Meet specific data and quality targets for case handling
Remain current with case handling SOPs, guidance documents and database technology
Organizes workload to ensure compliance with SDEA and other global regulatory reporting requirements for ICSR.
Demonstrates general understanding of appropriate labeling documents for Client products.
Ensures departmental workflow processes and timelines are followed Works with Submissions Team to properly identify global regulatory reporting requirements especially for Client sponsored clinical trials reports.
May assist manager in the preparation of training material and assist in training new employees.
Perform clinical trial reconciliation with minimal supervision from Manager or Sr. Safety Specialist.
Identify cases requiring investigator letters and draft investigator letters with minimal supervision from Manager or Sr. Safety Specialist.
May triage and assign the incoming reports.
Participate in some clinical trial activities with supervision from Manager or Sr. Safety Specialist (i.e., protocol & CRF reviews, data management plan reviews, CRO agreements & flows).
May participates in Study Management Teams (as applicable).
May assists in the development of drug safety presentation for investigator meeting presentations.
Qualifications Excellent interpersonal and communication skills, both written and oral.
Safety database and data entry experience preferred.
Understanding of medical terminology and the ability to summarize medical information is preferred.
The ability to assess data and understand the medical/safety implications.
Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred.
A quality driven individual with strong attention to detail and accuracy is required.
A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required.
Ability to follow guidelines and procedural documents Self-motivated and capable of working independently.
Understands safety database structures and is familiar with data retrieval tools.
Case processing experience is preferred.
Knowledge of clinical trials activities preferred.
Medical Safety Coding (MSC) Works independently with little or no supervision.
Supports MSC Coding Group if assigned and ensures coding of adverse event and medication terms for clinical and post-marketing data using the MedDRA and WHO Drug coding dictionaries, and collaborates with Clinical Data Management (CDM) to ensure timely completion of coding jobs.
Maintains metrics log of MSC document reviews or coding jobs.
Generates reports from internal safety or coding database.
Contributes toward completion of organizational projects and goals, and maintains meticulous attention to project deadlines.
Interdepartmental contacts are frequent and involve planning and preparation of communications, along with skill, tact, persuasion, and/or negotiation to accomplish.