Job Details

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The Opportunity
Description
We're looking for a Drug Safety Associate, working in Biotechnology/Medical Devices industry in 350 DNA Way, South San Francisco, California, 94080, United States.

Responsibilities:

• Establishes work priorities and direction independently with minimal input from Manager.
• Collects, documents, and processes adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance.
• Prepares clinical narrative summaries independently for AE reports from clinical studies and spontaneous post-marketing reports and formulates follow-up information requests.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

Skills:

• Health care professional degree (PharmD, RN, MD)
• Atleast 2 years drug safety experience AND additional clinical or pharmaceutical experience
• Strong verbal and written communication skills demonstrated by the ability to interpret and communicate medical information and write summary reports, if needed
• Strong interpersonal skills especially for proactive drug safety representation on clinical/project team and investigator meetings, and communications with contract research organizations (CROs) involved in safety reporting
• Must have the ability to organize workflow activities, able to multi-task, be performance-driven, and possess good decision-making skills
• Computer literacy including working knowledge of computer applications such as word processing, spreadsheets and electronic mail is required; experience with data entry into drug safety databases strongly desired; ARISg experience a plus
• Knowledge of domestic and international drug safety regulations, industry practices and standards as well as clinical knowledge in appropriate therapeutic area is preferred

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?