Drug Safety Associate
Proclinical is currently recruiting for a Drug Safety Associate with a biopharmaceutical company located in San Jose, CA.
- 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
- 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
- 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
- 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)
- 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
- Works with Submissions Team to properly identify global regulatory reporting requirements especially for 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
- May triage and assign the incoming reports
- 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)
- May assists in the development of drug safety presentation for investigator meeting presentations
Skills and Requirements:
- Safety database and data entry experience preferred
- Understanding of medical terminology and the ability to summarize medical information is preferred
- Case processing experience is preferred
- Knowledge of clinical trials activities 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
- Excellent interpersonal and communication skills, both written and oral
- Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word)
- 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
- Understands safety database structures and is familiar with data retrieval tools
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 contact Hannah Cihlar at 267-983-0133 or upload your resume 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.
Proclinical Staffing is an equal opportunity employer.