On behalf of a client, we are currently recruiting for an Executive Vigilance Assessor, Vigilance Assessment - Human Products Monitoring. This is a 3 year contract role initially. This is a hybrid role with 3 days in Dublin City office and 2 days remote.
Reporting to the Vigilance Assessment Manager the role of the Executive Vigilance Assessor is to proactively participate in the management, development and operation of the Vigilance Assessment section.
The Executive Vigilance Assessor will achieve this through the following key aspects:
o 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.
o Coordinating a strategic scientific quality assurance approach to vigilance assessment activities, supporting an excellence in pharmacovigilance model across the section.
o Acting as a subject matter expert, contributing to cross departmental and organisational initiatives, as well as representing the company on technical matters relevant to the remit of vigilance assessment.
o Leading 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.
o Performing signal management and evaluation of new and emerging data from a variety of data streams.
o Ensuring 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.
o Deputise for colleagues and to ensure appropriate cover within the Vigilance Assessment section as required.
o Other duties as may be required with regard to the post marketing regulation of human medicines.
QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must have:
o A degree in pharmacy or other relevant scientific discipline.
o Post graduate qualification in a relevant scientific or related discipline or equivalent level of expertise in vigilance assessment.
o 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.
o Relevant research experience, with proven ability to critically analyse data. o Proven ability to develop methodologies and policy approaches for vigilance related matters. o In depth knowledge of EU legislation and guidelines relating to vigilance assessment. o Excellent oral and written communication skills and interpersonal skills.
o Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
o Demonstrated ability to meet deadlines.
o Excellent interpersonal, organisational and communication skills.
o Experience of working collaboratively within departmental and cross-organisational teams in a solution focussed manner.
o Experience of high level involvement in EU level pharmacovigilance scientific committees or working groups.
- In addition, the following would be considered an advantage: o A postgraduate qualification, publications or equivalent demonstrated excellence in pharmacoepidemiology and biostatistics.
o Experience in contributing to EU pharmacovigilance guidelines and initiatives.
o Experience of high-level representation of organisational/national positions at National/European level.
o Experience in mentoring staff.
o Ability to motivate a team and maintain output and productivity to a high standard.
For full details contact Linda at +353 1 2784701 or email your CV to email@example.com
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com