An exciting opportunity has arisen for a Drug Safety Public Health Specialist to join a global biopharmaceutical company based in Foster City, California. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
Job Role and Responsibilities:
- Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing 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.
- 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 company products.
- Ensures departmental workflow processes and timelines are followed
- Works with Submissions Team to properly identify global regulatory reporting requirements especially for company sponsored clinical trials reports
- May assist manager in the preparation of training material and assist in training new employees
- May assist with other projects as necessary (i.e, study unblinding).
- 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
- Acts as a trainer and mentor for more junior staff members.
- 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)
- Must be proficient in written and verbal communication. 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.
- Sets work priorities and direction with input from Manager.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please send your CV to Eleni Farrell on [click here] or upload on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.