Job Category: Clinical Affairs
Job Number: 12020853
Akraya is looking for a Drug Safety Public Health Specialist for one of our clients. If the job description below is a fit, please apply directly or call Vaibhav Kalbende & 408-512-2355. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Drug Safety, CROs, Word, Excel, and PowerPoint, regulatory
Duration: 6 Months
Tax Term: W2 Only
- Contributes to full life cycle of safety data retrieval activities data query, authoring, validation and publishing reports. Executes validation protocols.
- 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.
- Review, enter, and verify follow-up information for cases and make accurate determination of significant information 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.
- Identifies issues/concerns in a timely and appropriate manner 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.
- 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 Demonstrates initiative, teamwork and accountability Demonstrated success working both independently and in collaboration with others A quality driven individual with strong attention to detail and accuracy is required Strong organizational skills, and ability to adapt to change A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strick 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.
- Demonstrates excellent attention to detail, teamwork and initiative; maintains confidentiality.
- Contributes toward completion of organizational projects and goals, and maintains meticulous attention to project deadlines.
- Recognizes and seeks interdepartmental assistance for missing data.
- Interdepartmental contacts are frequent and involve planning and preparation of communications, along with skill, tact, persuasion, and/or negotiation to accomplish.
Please apply directly with your updated resume or call Vaibhav Kalbende @ 408-512-2355
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.