Director, Global Safety and Quality Job in Dallas, Texas US
Job Category: Legal
Type: Full Time, Employee
Salary: $130,000.00 - $170,000.00 /year
Bonus and relocation
Minimum Education: Bachelor's Degree
Director, Global Safety and Quality
Job Summary:
Leads Global Safety Systems and Quality Management functions under direction of head of Global Vigilance Operations; leads MS Audit planning in conjunction with corporate QA department; leads interdepartmental audit preparedness activities; verifies that QM activities are aligned with department and company strategy; leads and evaluates regulatory intelligence and its impact on the department; leads the consultation process on new regulations and guidance; identifies departmental opportunities for improved process efficiencies and implements change; responsible for negotiating all departmental Vigilance agreements.
Leads Global Safety Systems in Medical Safety and all interactions with Global Information Technology; member of the Medical Safety Management Team; identifies and recommends strategy for enhancing global safety systems operations; contributes to corporate cross-functional projects and serves as spokesperson for IT issues in Medical Safety; responsible for production and maintenance of global safety systems plan as component of Medical Safety Plan; liaises with GIT in the implementation of safety database validated systems change requests and upgrades; acts as spokesperson on safety systems matters via appropriate communications at external Drug Safety meetings and User Conferences.
Manages the following: Contributions by group to enhanced practices in Medical Safety via development of standardized practices, procedures, metrics and measures of productivity and performance; coordination of activities in Safety Systems to insure harmonized approach to problem solving; work with GIT to identify budget for Safety Systems projects; project management shared responsibility with GIT for Medical Safety projects.
Technical Expertise: Provide support for on-going and periodic quality audits of data for assigned systems; responsible for operational support, configuration management and administration of the Safety Databases; provide expert guidance on validation and quality issues; evaluate new safety database modules and software upgrades; design and generate ad-hoc reports/queries for internal and external stakeholders.
Coach and Mentor: Supervises the members of Global Safety Systems and Quality Management group; provide guidance to Medical Safety personnel as required to avert or resolve technical problems.
Minimum Education Requirements:
BS or RN/BSN or RPh or equivalent education degree.
Minimum Experience Requirements:
Knowledge and understanding of FDA and EMEA regulations and guidelines pertaining to safety of drugs and devices, ICH guidelines, GMPs and GCPs.
9-13 years of drug safety experience and additional experience in periodic reporting or safety surveillance practices is preferable with a Bachelors Degree.
7-11 years of drug safety experience and additional experience in periodic reporting or safety surveillance practices is preferable.
Quality professional with training in Quality methods e.g. Six Sigma and membership in ASQ (American Society of Quality).
Experience of devices is preferable but we will look at Pharma quality management professionals.
Knowledge of international drug safety regulations and best practices (CIOMS) is required.
Five (5) years experience in pharmaceutical industry with responsibilities in Safety Systems (pharmacovigilance I.T.) in a pharmacovigilance department.
Knowledge of commercial safety databases required and knowledge of Trackwise (product complaints database) is an advantage.
Experience with electronic submissions of safety data to regulatory authorities is required.