Quality Specialist, Pharmacovigilance

<h2>Job Overview:</h2><ul><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Perform Quality review of assigned cases </span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in compiling quality metrics based on this review and identifying quality trends </span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in addressing periodic client quality reviews</span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in preparation of Corrective and preventive actions as requested</span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers</span><ul><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in the conduct of process review for assigned process and measure and monitor audit readiness </span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in designing and tracking training schedule and training material for new hires and existing team.</span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Contribute to discussion forums on Quality errors within assigned project and help identify process improvements</span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in coordinating respective client or external audits of the assigned projects as requested</span></li><li style="margin-left: 22.3pt;"><span style="font-size: 12pt; font-family: verdana, geneva;">Assist in development of Quality Management Plan for assigned project</span></li></ul><span style="font-size: 12pt; font-family: verdana, geneva;">Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Bachelors/Masters degree in Medicine or Alternative medicine or Pharmaceutical science</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">2 plus years of overall work experience in the functional area with one year in Peer review/Quality review</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Bachelors/Masters degree in Medicine or Alternative medicine or Pharmaceutical science</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">2 plus years of overall work experience in the functional area with one year in Peer review/Quality review </span></li></ul>