Area/Local Safety Officer Consultant

## Responsibilities - 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. ## Requirements - Confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. - Experience in managing safety activities related to all products in compliance with local regulations and company policies/procedures at a local, regional, and global levels. - Experience in working with product vigilance agreements with third party business partners. - Strong understanding of pharmacovigilance, cosmetic and device vigilances including reporting requirements. - Ability to maintain KPI and present them during regular team meetings. - Ability to perform regulatory monitoring for impact on vigilance activities and responsibilities. - Ability to perform reconciliation with other departments (distributors, third parties, vendors, and internal stakeholders). - Ability to maintain up-to-date knowledge of local requirements for pharmacovigilance, cosmetic and device vigilances including reporting requirements. ## Nice to Have - Experience in a global CRO environment. - Experience in working with a single sponsor. - Experience in managing safety reports and submissions to local health authorities. - Experience in training local employees and business partners. ## Benefits - Working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring. - 12 months Contract with possibility of extension. - Opportunity to work with a global CRO with a strong focus on quality, professional development, and supportive culture.