Vibrant, medium-size pharmaceutical company in San Francisco Bay Area is looking for a Senior Drug Safety Associate. Relocation necessary, some assistance available. Top 50 places to work in the SF Bay Area!
The Senior Drug Safety Associate will be responsible for the evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines and pertinent licensing agreements.
The Senior Drug Safety Associate will:
• Review and approval of adverse event reports processed by others
• Follow up with physicians and other health care professionals and consumers, as appropriate and ensure that adverse events are entered into company safety system accurately.
• Identify safety signals and providing data analyses and summaries and assisting in responding to queries from health authorities, partners, or outside sources.
• Participate on clinical teams independently making decisions and providing guidance to project teams and work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Be responsible for CRF review and assisting in establishing rules for SAE reporting procedures, The Sr. DSA may assist in the development of Periodic Safety Update Reports and Periodic Reports.
Job Requirements :
Essential Requirements:
• Degree in health related field
• Two plus years relevant experience within the pharmaceutical industry
• Knowledge of MedDRA
• Working knowledge of pharmacovigilance and clinical safety regulations and guidelines
• Ability to independently identify problems and effectively offer solutions to problems
• Must have excellent communication skills, resourcefulness, and personal organization skills
• Must be committed to working as part of a team in a fast-paced environment
• Experience using safety databases is required
Send resume for consideration. Good luck!
- Location: California-SF Bay Area
- Compensation: Based on Experience. EEO employer. Health/Vision/Dental. 401k. Stock options/profit sharing. More
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- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.