Medical Director, Clinical Drug Safety

Medical Director, Clinical Drug Safety

In this newly created role, you will provide medical review for clinical and post marketing adverse event reports and will prepare and review periodic safety/expert reports. Additional responsibilities include: support Risk Management activities including contribution to RiskMAPs; support regulatory authority inspections; work closely with clinical project teams providing safety input; participate on risk management committees; prepare and review AE section for IBs, company core labeling and clinical study reports; respond to regulatory authority queries on product safety issues; and evaluate the adverse event profiles of potential in-licensed products as part of due diligence. Qualifications include: an MD and Board Certified (Psychiatry specialty is preferred); 10 years clinical drug safety/pharmaceutical industry experience required; a minimum 5 years experience in medical assessment of adverse event reports; experience in use of ARISG/MedDRA dictionaries; 5-10 years of risk management experience in pharmaceutical industry; and previous medical writing experience is a plus.

Please refer to job code KY6725 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Safety
Location:	Ridgefield, NJ
County:	Bergen County
ZIP Code:	07657
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856