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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Executive Vigilance Assessor


Reference:SCACWD-304504 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Executive Vigilance Assessor
Our client, a large regulatory body are currently recruiting for an Executive Vigilance Assessor to join their team.

Responsibilities

  • Line management of department personnel and assisting the Vigilance Assessment Manager in defining objectives, settings targets, coordinating activities, agreeing priorities, developing team members and maintaining effective communication lines
  • Coordinate a strategic scientific quality assurance approach to vigilance assessment activities, supporting an excellence in pharmacovigilance model across the section
  • Act as a subject matter expert, contributing to cross departmental and organisational initiatives, as well as representing the organisation on technical matters relevant to the remit of vigilance assessment
  • Lead assessment of Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), Post Marketing Commitments (PMCs), Post-Authorisation Safety Studies (PASS), referral procedures, PRAC-led variations and risk minimisation plans
  • Performing signal management and evaluation of new and emerging data from a variety of data streams
  • Ensure that the required scientific expertise, standards, policies and practices are in place for the assessment of all application types received and ensuring robust scientific decisions underpin the advice, recommendations, conclusions as well as any actions arising from post-market surveillance activities
  • Deputise for colleagues and to ensure appropriate cover within the Vigilance Assessment section as required
Requirements
  • A degree in pharmacy or other relevant scientific discipline
  • A postgraduate qualification, publications or equivalent demonstrated excellence in pharmacoepidemiology and biostatistics
  • Post graduate qualification in a relevant scientific or related discipline or equivalent level of expertise in vigilance assessment
  • Experience in contributing to EU pharmacovigilance guidelines and initiatives
  • A minimum of 3 years’ vigilance assessment experience, including in leading the assessment of a wide range of vigilance assessment procedures including risk management plans for initial Marketing Authorisation Applications, signal detection and management, PSUSA procedures where Ireland has acted as PRAC Rapporteur or Lead Member State and assessment of risk minimisation communications and tools at national level
  • Relevant research experience, with proven ability to critically analyse data
  • Proven ability to develop methodologies and policy approaches for vigilance related matters
  • In depth knowledge of EU legislation and guidelines relating to vigilance assessment
  • Excellent oral and written communication skills and interpersonal skills
  • Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome
  • Demonstrated ability to meet deadlines
  • Excellent interpersonal, organisational and communication skills
  • Experience of working collaboratively within departmental and cross-organisational teams in a solution focussed manner
  • Experience of high level involvement in EU level pharmacovigilance scientific committees or working groups
  • Experience of high-level representation of organisational/national positions at National/European level
  • Experience in mentoring staff
  • Ability to motivate a team and maintain output and productivity to a high standard
For more information contact Sinéad Cullen on +353879500821 or [email protected]