ClinChoice - Area/Local Safety Officer Consultant
Requirements
• Education: health care science professional or equivalent training • 2-4 years of relevant experience (e.g. case data management, reconciliation manager, vigilance IT project manager…). • Fluent in English. French as a mother tongue. • Excellent communication skills and ability to work with cross-functional teams. • Rigor is a key skill for this mission. • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
Responsibilities
• Safety and PV System Management • Perform the quality check of the PV cases and ensure that the English translation has been properly performed. • Keep up to date a local tracker of the individual safety reports. • Be the subject matter expert at local level on the case management activities. • 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. • Establish and maintain local indicators on the compliance of the safety reports submission. • Oversee the training of the local employees and the business partners. Maintain KPI and present them during regular team meetings. • Perform regulatory monitoring for impact on vigilance activities and responsibilities. • Perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). • Maintain oversight of proper identification of local literature articles for AE reporting as required. • Perform reporting/ submissions of safety reports/ updates/information (e.g., SAE, SUE, SUSARs, PSUR, RMP) to local health authorities and other Client departments as applicable. • Supporting Area Safety Lead in notifying local health authorities of any safety issues including SSI/ESI and Signals. • Maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements (for all applicable product classes in the territory) and collaborating with the global team to implement process changes required for identification of new requirements. • Record self-identified non-conformances and collaborating with the global team to investigate non-conformances while developing and implementing effective CAPAs. • Perform other agreed tasks assigned by manager • Perform document management and archiving as required • Procedural Document • Procedural Document • Ensure current knowledge of all relevant company procedures and training. • Develop, update, and implement local procedures to ensure compliance with Clients global procedures and national requirements. • Audit & Inspection readiness • Support in local health authority inspections and audits conducted locally, including responding to queries during the conduct and collaborating with the global team to develop and implement CAPA (Corrective and Preventative Action) plans as applicable • PV contract management • Provide PV clauses to be included within local agreements and contribute to the PSMF with contracts-related information • Business Continuity • Business Continuity • Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)
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