Sr. DSA
About the role
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Drug Safety Associate
Competitive package
Location – North Wales, Pa
The successful candidate will process and track Serious Adverse Events, serious and non-serious adverse drug reactions, and other medically related project information. They will also ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.
Overview of the Role
- Document and process Serious Adverse Events, spontaneously reported adverse events and other medically related information per study specific procedures
- Provide input for and review relevant safety tracking systems for accuracy and quality
- Perform safety review of clinical data (case report forms) and patient labs
- Assist Medical Monitor with documentation and processing routine exception and re-screen approvals
- Actively identify out of scope activities in conjunction with the Medical Monitor and/or Project Manager and Liaise with investigational sites and/or reporters regarding safety issues
- Serve as a medical resource for investigational sites and ICON personnel on safety related issues
- Assist with safety related training for extra-departmental ICON staff as requested
- Attend project team meetings and teleconferences
- Complete assigned departmental activities accurately and in accordance with regulatory requirements, ICON standards and Sponsor contracts
- Liaise with Sponsor and attend Sponsor meetings, as required
Role Requirements / Skills / Experience Required
- Qualified candidate must have medical/science background (nursing preferred) with relevant clinical experience.
- Minimum of 2 years of drug safety experience preferred.
- Knowledge of Microsoft Office applications and medical terminology required.
- Must possess excellent communication and organizational skills.
- Ability and willingness to travel 10% or as needed.
- Perform DSMB related activities as required
Benefits
Working for ICON Medical Imaging you will be provided with an excellent benefits package.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON Medical Imaging.
What’s Next
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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