Title : Sr. Director, Medical Safety Surveillance and Scientific Services-1311954

 

JOB DESCRIPTION

 

If hired, the candidate would become a member of Quintiles’ global Medical Safety Surveillance Team located in the Therapeutic Delivery Unit and become the US Regional Head.  He or She would be office based in RTP or another US based Quintiles office. He or She would be expected to perform all tasks of a medical safety surveillance physician for client projects spanning clinical trials and post-approval programs and develop team members in the performance of said tasks.  He or She would be expected to know global safety-regulatory reporting algorithms and be an expert in pharmaceutical safety services. Tasks would include:

·         Line Manage a team of regionally based physicians performing the tasks of a global medical safety surveillance physician

·         Participate in the Global Medical Safety Surveillance Management Team to drive service line growth, differentiation, and strategy

·         Represent service line to regional stakeholders, internal and external

·         Attend key meetings pertinent to service line and maintain connections with key clients of service line

·         Consult and provide operational support for all levels of medical safety surveillance services from adverse event case reviews to risk management program development

·         Perform review and clarification of trial-related Adverse Events (AEs) including narrative content, coding, expectedness, seriousness, and causality

·         Perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives

·         Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile

·         Provide medical support for the Analysis of Similar Events (AOSE)

·         Compose and review IND Annual Reports, EU Annual Safety Reports, Periodic Reports or Periodic Safety Update Reports

·         Provide medical insight and review of EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies

·         Compose Development Risk Management Plans

·         Provide medical oversight for label development, review and change

·         Provide medical support and attendance at Data Safety Monitoring Board Meetings

·         Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document

·         Provide medical oversight of medical information projects

·         Provide medical oversight and reference for EU Qualified Persons for Pharmacovigilance

·         Maintain awareness of industry developments and participates in professional meetings, and  author related publications

·         Propose and resource projects involving safety services

·         Account for financial performance of safety projects

·         Serve as a resource, and may participate in strategic business development activities including presentations to prospective clients, professional meetings, and other business development   activities

·         Ensure that departmental goals, objectives, policies, and procedures are communicated, understood, and implemented

·         Supervise assigned direct reports and provides mentoring as required

·         Recommend course of action on management/human resources matters, including salary administration, transfers, hiring, terminations, professional development, performance appraisals, and employee counseling

·          Identify ongoing training and development needs of assigned staff

·         Evaluate assigned staff workload and creates volume projections in order to ensure appropriate balance of project assignments for direct reports

·         Perform special projects as requested by management

See  https://quintiles.taleo.net/careersection/10080/jobdetail.ftl

Qualifications

 

QUALIFICATIONS

 

A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he/she resides and works is required, plus a minimum of 5 years experience in clinical medicine. 8 years of clinical development experience in the Pharma, CRO, or Biotech industry and drug safety is required. Specialty Board certification is desirable; or equivalent combination of education, training and experience.

·         Knowledge of or Experience in Clinical Trials and Pharmaceutical Research Process

·         Ability to establish and meet priorities, deadlines, and objectives

·         Skills in providing consultation and advice on multiple assignments as well as initiative and flexibility

·         Ability to establish and maintain effective working relationships with coworkers, managers, and clients

 

Primary Location

: USA-North Carolina-Research Triangle Park

Organization

: USA02 - US Clinical Development Svcs