This position is responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations. Additionally responsible for strategies in monitoring and analysis of cumulative safety information on products. Responsible for drug safety crisis management

Specific responsibilities include:

Guides regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and Periodic Safety Update Reports (PSURs)

Guides adverse event coding, retrieval and analysis activities in drug safety and clinical trials

Guides reviews of safety sections of NDA submissions

Plans cumulative safety information analysis such as signal detection from company or public databases with data mining

Guides safety updates of company core data sheet and local product labels

Guides pharmacoepidemiology projects

Guides crisis management on drug safety

Guides Risk Management Plans for specific products

Guides and coordinates preparation of ad-hoc benefit-risk assessment documents

Guides regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees

Interfaces with Medical Sciences, Clinical Studies, Product Safety Management, Drug Development and Project Management, Pharmacoepidemiology, Global Pharmacovigilance departments, Toxicologist, Biopharmaceutical sciences, Research Data Sciences, Legal

Demonstrated leadership skills and strategic focus. Demonstrated ability to exercise independent judgment and effectively collaborate with multiple functional units

Requirements
MD degree, Pharmaceutical Industry experience in Pharmacovigilance and drug safety for at least five years, Team working, analytical skills, and flexibility are essential for this position. Required 3 years of direct experience in oncology

Regards,

Matt Ballinger
Permanent Division
Smith Hanley Associates LLC
780 Third Ave, 8th Floor
New York, NY 10017
mballinger@smithhanley.com