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Job Details

Director, Pharmacovigilance - UK-152250

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge
Reference: 152250
Closing Date: 13 Jan 19
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

  An exciting opportunity has arisen within the UK Pharmacovigilance team, and we are now looking to appoint a Director a permanent basisResponsibilities of the Director include the general oversight of the UK Pharmacovigilance (PVG) operations and management of the activities of Managers, PVG, Safety Specialists and other PVG staff. ...

Requirements:

  An exciting opportunity has arisen within the UK Pharmacovigilance team, and we are now looking to appoint a Director a permanent basis

Responsibilities of the Director include the general oversight of the UK Pharmacovigilance (PVG) operations and management of the activities of Managers, PVG, Safety Specialists and other PVG staff.    Other activities include provide direction, support and training for PVG staff, oversee study start-up procedures, oversee safety database activities, development and maintenance of departmental Standard Operating Procedures/Working Practice Documents, and long-range planning for new processes and staffing needs.    The Director is ultimately responsible for ensuring that the services are provided in accordance with the client and PVG policies, procedures and contractual agreements. The Director is responsible for ensuring project report summaries, budget, audit readiness, staffing decisions, and other critical issues are managed appropriately. Additional responsibilities are preparation of business proposals and client presentations, interacting on a day-to-day basis with members of the Business Development and Bids and Contracts groups.

Qualifications

  Education and Experience:
  • BS or BA in Health Science or health science field
  • 6 - 8 years experience in clinical research, including 5 years Pharmacovigilance/Safety experience
  • 5 years management experience (included within the total experience) Or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
  Knowledge, Skills and Abilities:
  • Expertise in budgeting, forecasting and fiscal management
  • Ability to effectively supervise and objectively evaluate divisional staff
  • Expertise in motivating and integrating teams
  • Analytical skill as well as excellence in oral and written communications
  • Ability to travel up to 25% or more, sometimes on short notice
  • Ability to handle multiple issues on multiple projects simultaneously
  • Ability to maintain a high degree of independence with respect to decision making and problem solving
  • Expert knowledge of regulatory guidelines for adverse event reporting
  • Must have thorough experience in safety database activities including regulatory reporting and system validation
  • Ability to act as liaison with other Divisions necessary to complete contract/regulatory requirements (i.e., Data management, Clinical, Regulatory Affairs, Biostatistics, Medical Writing, etc.)
  • Liaise with Business Development and present safety services to sponsor.
  • Ability to prepare proposals for PVG  activities
  • Expert knowledge of PPD Standard Operating Procedures, FDA regulations, ICH guidelines, and Good Clinical Practices
  • Excellent communication skills
  • Strong negotiating skills
  • Must have ability to analyze and evaluate processes and procedures

*LI-EP1

Apply for this job: Director, Pharmacovigilance - UK-152250

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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