Associate, Global Product Safety - 2407

Job Description:
ICOS Corporation, based in the Seattle, Washington area, has spent more than a decade building a world-class research and development organization. Cialis is currently available in approximately 100 countries, including Australia, Brazil, Mexico, Canada, the United States and countries throughout Europe. ICOS is committed to advancing science in the areas of protein based and small molecule therapeutics.

Responsibilities:

Support the pharmacovigilance activities for ICOS products including:

Process safety data from investigational clinical trials and post market reports in compliance with domestic and international regulations.
Contribute to the submission of reports to regulatory agencies
Assist with the preparation of FDA and international Individual Case Safety Reports (ICSRs) and aggregate reports (e.g., IND annual reports, PSUR, PADER) for internal (e.g., ICOS) and external (e.g., regulatory authorities) customers.
Act as liaisons with internal and external business partners to meet global regulatory reporting requirements.
Participate in cross-functional teams and assist with special projects as needed.

Requirements:

PharmD and 1 year of clinical experience or Healthcare degree (BSRN, BPharm,) and 2+ years experience in safety department
Experience with computer based applications (e.g., Microsoft Word, Excel, PowerPoint).
Excellent written and verbal communication skills.
Excellent interpersonal skills.
Excellent organizational skills.
Detail oriented.
Ability to work proactively.
Excellent problem solving skills.
Excellent leadership skills.
Project management experience desirable.

ICOS offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. EOE

For immediate consideration please email your CV to Karen Fenstermacher at kfenstermacher@icos.com highlighting the position in the subject line or visit www.icos.com and apply directly for this position.

Learn more about ICOS philosophies, attributes, financial information, and more by visiting our web site at: www.ICOS.com

Searchable Keywords: Associate, Global Product Safety - 2407 / gj-mo

Expected Travel Time: None