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Job Title: Associate Director/Director/Senior Director, Drug Safety and Pharmacovigilance
Description:
The Associate Director/Director/Senior Director, Drug Safety and Pharmacovigilance will oversee clinical operations, processes and procedures of the Drug Safety and Pharmacovigilance functional area, including development and review of safety reports, assessment of safety signals, and contribution to clinical and regulatory documents. This position is responsible for the safety and medical surveillance of products in clinical development, including proactive strategies to prevent risk and promote safety of patients enrolled in Cougar-sponsored and investigator-initiated trials. Demonstrated knowledge of regulatory requirements pertaining to Drug Safety and Pharmacovigilance as well as knowledgeable in the use of MedDRA required. Able to deal with safety related issues using critical medical and regulatory analytical strategies to develop optimal solutions.
This position reports to the Senior VP, Clinical Research and Development. Managerial responsibilities may be required.
Qualifications:
M.D. degree is required. Board Certification in a medical specialty and a minimum of 2-4 years in clinical practice in a relevant setting are preferred. Oncology or internal medicine background as well as industry drug safety experience are preferred.
The successful candidate must have experience in or knowledge about drug-development procedures. Knowledge of regulatory requirements pertaining to drug safety/pharmacovigilance as well as the use of MedDRA are required. Able to deal with safety related issues using critical medical and regulatory analytical strategies to develop optimal solutions. Experience in drug safety/pharmacovigilance and familiarity with regulatory guidelines and requirements are highly desired.
Compensation:
Commensurate with experience
Date Posted: 01/16/2008
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
