Romeo Consulting

DRUG SAFETY SCIENTIST

How to Apply for this Job
Company: Romeo Consulting Contact Name: Paul Romeo Email your resume (Click Here) Mail To: 309 Fellowship Road Suite 210 Mt. Laurel New Jersey 08054 Phone: 856-642-4054 Use one of the above methods to apply for this job.

• Job ID:
• Date:06/27/2008
• Location:San Francisco
• State:California
• Degree:Pharma. D
• Current Professional Level:Experienced Staff Level
• Salary:Not Specified   Why?

Job Types:

Post-Market Surveillance, RESEARCH & DEVELOPMENT (Drug), Scientist

Develops and coordinates safety surveillance for designated products in support of clinical programs involving investigational and post-marketing studies. Formulates safety surveillance policies and procedures to ensure compliance with adverse event reporting requirements, interprets and evaluates the medical significance of incoming safety information received from internal and external customers, serves as the drug information and drug safety resource on assigned Clinical Development Teams. Prepares ad hoc safety reports for regulatory authorities and contributes to the medical information data base. Establishes and supervises Adverse Event (AE) reporting for assigned products and determines course of action and triage based on internal policies and procedures; ensures compliance with FDA/ICH and other international AE reporting requirements. Monitors, evaluates and interprets the safety profile of assigned products and recommends labeling updates or amendments as warranted. Prepares safety summaries for inclusion in medical information reports and other ad hoc safety reports. Communicates benefit/risk analysis and provides product safety profiles to internal/external customers. Prepares and processes internal/external AE reports to include writing detailed safety summaries and identifying and reconciling of AE data collection problems. Participates in responding to safety inquiries from regulatory authorities or third parties worldwide for assigned products. Participates on Clinical Development Teams and Postmarketing Project Teams and interacts extensively with Medical Monitors and other Medical Affairs personnel. As required, supervises the activities of other Drug Safety personnel.

REQUIREMENTS: Pharm.D. or M.D. with significant experience in drug safety surveillance. Experience must include an understanding of drug safety concepts and adverse event reporting of drug products. Industry experience is preferred. Knowledge of regulations pertaining to investigational and post marketing drug safety surveillance; knowledge of pharmacovigilance initiatives; regulatory oversight; and regulatory/medical/labeling issues impacting drug safety. Must have strong medical writing skills and computer literacy, including working with clinical/medical databases. Must have effective leadership and supervisory experience; strong communication skills, including presentation skills.

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