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Manager, Safety/Pharmacovigilance

INC Research

Sofia, Bulgaria

Description

Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You’ll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.

To strengthen this group we are seeking a Manager to be responsible for a team of Safety Specialists to be based in any of our European offices.

A brief summary of duties you will be involved in as a Manager, Safety/Pharmacovigilance:

  • Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, job description preparation, time sheet approval, and employee counseling;
  • Assigning project work and reviews workload for all direct reports. Providing oversight and guidance on organizational goals and company objectives;
  • Monitoring quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discussing below-target project goals with Associate Director/Director/VP;
  • Managing projects where Safety and Pharmacovigilance are the primary services:
    • Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed;
    • Works with Finance to ensure appropriate customer invoicing, where required;
    • Approves project time cards and invoicing;
    • Provides sponsors with scheduled project updates and reports.
  • Participates in the management of the Safety and Pharmacovigilance department with the following actions:
    • Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) or ensures compliance with sponsor SOPs;
    • Ensures the execution of the Safety Management Plan/Safety Reporting Plan;
    • Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions.
  • Works with Business Development to actively solicit new business, as needed;
  • Reviews, advises, and approves drug safety portions of project proposals to ensure wording adequately reflects the scope of work for drug safety. Reviews and approves clinical safety sections of study protocols and Case Report Forms (CRFs). Approves budget projections for the project;
  • Maintains understanding of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.

Qualifications

Skills and attributes:

  • BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree;
  • Moderate clinical research/drug safety experience or an equivalent combination of education and experience;
  • Progressive responsibility with demonstrated leadership skills;
  • Clinical Research Organization (CRO) experience with therapeutic specialties preferred;
  • Working knowledge of financial budgets and various financial analysis tools preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), email, and internet;
  • Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills;
  • Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment;
  • Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment.

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