ICON Clinical Research Drug Safety Associate - Safety Reporting Group in Warsaw, Poland
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As part of our Safety Reporting Group in ICON’s Global Regulatory Affairs Department, our DSA’s contribute to our culture of process improvement, perform expedited and periodic safety reporting, maintain projects and liaise with Sponsors, ICON project managers and investigational sites as required.
Purpose of the Role*
As a DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, and Principal Investigators and business partners.
Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.
Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors.
The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
Must be fluent in written and verbal English with good communication skills and basic computer skills. Detail orientated and capable of working effectively within a team environment.
Medical/science background and/or bachelor’s degree or local equivalent.
We are a company of 13,500 employees in eighty global locations. We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster in a more cost-effective way with better patient outcomes. We are a top five organization with solid earnings and growth potential. Our belief in excellence is our core value in all that we do for our sponsor partners and the patients that we serve. As a company we strive to exceed our customers’ expectations in drug development solutions.