Senior Drug Safety Associate (Regulatory)

Sr. Drug Safety Associate

Are you interested in performing case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically-related project information such as adverse events of special interest and clinical endpoints?  Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information.  Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors.

Sr. Drug Safety Associate role within ICON: 

The Drug Safety Associate will complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes. Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files. Perform safety review of clinical and diagnostic data under supervision. Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues under supervision. Travel (up to approximately 15%) domestic and/or international as applicable.

To succeed you will need:

We are seeking candidates with a medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent. Minimum of 2-3 years related experience in Clinical Research. To be successful you will be expected to be proficient in Microsoft Office skills (Word, Excel, and Access). Have good communication skills, be fluent in written and verbal English, detail-oriented and have the ability to work effectively within a team environment.

Benefits of working at ICON:

In addition to partnering with the top pharmaceutical and biotech companies in the world we offer a strong benefits package that includes a comprehensive health plan, retirement plans, competitive pay, bonus plans, vacation, and other incentives.  

ICON has a strong reputation in our approaches to clinical development.   We apply scientific and operational excellence across all phases of clinical trial outsourcing services for our clients.   We work with top pharmaceutical organizations on emerging therapeutic areas which include but are not limited to Oncology, Vaccines, CNS, Cardiovascular and Pain.  We are presently in over 40 countries with over 80 offices worldwide and over 10K employees globally. 

We invite you to review our opportunities at www.iconplc.com/careers.

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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