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Director, Safety and Pharmacovigilance

INC Research

Camberley, United Kingdom

Core Responsibilities:

  • Oversees financial performance of assigned units; develops and manages top and bottom line revenue growth and expense budgets for drug safety and pharmacovigilance;
  • Provides strategic leadership for drug safety and pharmacovigilance to achieve the Company’s mission, creating value for customers;
  • Evaluates and measures performance metrics and improves processes, as needed;
  • Directs the drug safety and pharmacovigilance associates to achieve on-time quality customer deliverables, contractual project requirements, utilization goals, and profitable results;
  • Identifies and develops associates to carry out required functions. Provides professional development and growth opportunities as appropriate;
  • Supports business development on project proposals. Assists in the creation, development and nurturing of key strategic customer relationships; develops strong relationships with current and prospective customers to generate new and/or add-on business;
  • Effectively leads and encourages collaboration and work sharing between offices to create a unified global safety and pharmacovigilance team. Ensures best practices and processes are followed globally;
  • Maintains current professional knowledge and expertise in fields of drug safety and pharmacovigilance to serve as a basis for providing “value added” expanded company services to all appropriate customers;
  • Line management responsibilities for associates. Approves course of action on salary administration, interviews, hiring, terminations, professional development, performance appraisals, job descriptions and training;
  • Implements quantifiable performance standards to facilitate improvement of global efficiencies and operational excellence;
  • Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, and the drug development process.

Qualifications

Skills and attributes:

  • BA/BS in biological sciences or related disciplines in the natural science/health care field/life sciences;
  • Extensive drug safety and/or pharmacovigilance experience in Contract Research Organization (CRO);
  • Significant client management experience;
  • Significant line management experience;
  • Contract Research Organization (CRO) experience preferred;
  • Oversight of multiple and complex trials and FSP type relationship strongly desired;
  • Extensive in-depth knowledge of global and local regulatory requirements; strong understanding and usage of medical terminology;
  • Ability to make effective decisions and manage multiple priorities to meet deadlines in a highly dynamic environment.

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