 |
Available Positions
|
|
» Back to Available Positions
Job Title: Sr. Manager/Associate Director, Global Safety
Description:
The Sr. Manager/Associate Director will provide proactive safety surveillance across the lifecycle of Cougar products in clinical development. He/she will follow established SOPs, GCP and other applicable regulatory requirements in the execution of all activities, including proactive and independent identification to resolve safety issues.
Responsibilities include the following:
- Manage and ensure compliant safety reporting in accordance with local and international reporting regulations and/or standard operating procedures
- Review clinical trial safety data and escalate possible safety issues as needed
- Generate periodic safety reports for assigned products
- Perform periodic safety data review according to a signal detection strategy and communicate findings to the Product Development Team (PDT) for assigned products, processes and procedures of the Drug Safety and Pharmacovigilance functional area
- Develop safety reports, manage safety database, and contribute to development of clinical and regulatory documents
- Participate in, coordinate or lead process improvement initiatives as required
Qualifications:
Candidates must have a bachelor's degree, doctoral degree or equivalent combination of education/experience in science or health-related field(s). A minimum 7 years of clinical trial experience, with at least 5 years of safety/clinical management in a pharmaceutical, biotechnology or CRO setting is required. Other desirable qualifications include thorough knowledge of regulatory requirements pertaining to drug safety/pharmacovigilance and the use of MedDRA; previous experience with adverse-event reporting systems, as well as FDA and EU drug safety/pharmacovigilance requirements.
Compensation:
Commensurate with experience
Date Posted: 04/23/2008
Email Résumé to info@cougarbiotechnology.com
» Back to Available Positions
|
| | |
Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
