Area/Local Safety Officer Consultant

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<p> </p> <p></p> <p> </p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….</span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong> </strong></span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>ClinChoice is searching for an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension </strong>to join one of our clients.</span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">The Area Safety Officer is responsible for ensuring that the local operating company (LOC) Safety activities related to all products are managed in compliance with local regulations and company policies/procedures at a local, regional, and global levels and in accordance with any product vigilance agreements with third party business partners<strong>.</strong></span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  </span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong> </strong></span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Main Job Tasks and Responsibilities: </strong></span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong> </strong></span></p> <p style="line-height: 1;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><strong>Safety and PV System Management </strong></span></p> <ul> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform the quality check of the PV cases and ensure that the English translation has been properly performed.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Keep up to date a local tracker of the individual safety reports.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Be the subject matter expert at local level on the case management activities.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Closely follow the respect of the regulatory timelines of the submission of the safety reports to the local health authorities and communicate any potential delay to the appropriate teams.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Establish and maintain local indicators on the compliance of the safety reports submission.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform regulatory monitoring for impact on vigilance activities and responsibilities.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders).</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">Maintain oversight of proper identification of local literature articles for AE reporting as required.</span></li> <li style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: tahoma, arial, helvetica, sans-serif;…