Area/Local Safety Officer Consultant

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…. ClinChoice is searching for an Area/Local Safety Officer Consultant for 12 months Contract with possibility of extension to join one of our clients. 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. 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.

Main Job Tasks and 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 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 Ensure implementation of local business continuity plans (e.g., inspection readiness, AE reporting coverage)

Education and Experience

Education: health care science professional or equivalent training

Significant training in data management with strong IT skills. 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? About ClinChoice 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.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Area Safety Officer, Local Safety Officer, PV, QC, CAPA,QPPV

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