My client is an International RTP, NC CRO--that has a focus in Drug Safety and Pharmacovigilance

Overview

Provides compliance leadership and oversight in strategic planning, analysis, development, implementation and measurement of all aspects of drug safety, Pharmacovigilance and risk management profile for the company. Reviews, plans and provides guidance on the implementation of corrective and preventive actions deemed necessary to ensure a quality environment. Provides leadership and strategic direction specifically to the Medical & Safety Sciences, Quality, Audit & Regulatory Compliance and Corporate Operations functions on a day to day basis.  Provide internal and external customer support as the Subject Matter Expert on Compliance and Risk Management topics.  Drive Risk Management and Quality, Audit and Regulatory Strategy Compliance initiatives to insure the CRO's client's  have the strategy to grow and sustain the clients organization proactively.

Requirements

Master’s or MD, or Ph.D. in Business Management or Life Science or related field and a minimum of 12-25 years of experience directly related to functions within the quality/regulatory or compliance disciplines serving in a strategic leadership role. Those individuals that have extensive Clinical Development and Drug Safety  experience Should have the relevant experience to provide Regulatory Strategy  in Phase III Trials.