Senior Drug Safety Associate (Regulatory)
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
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.
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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