Clinical Operations Specialist

Há 19 horas


Curitiba, Brasil Bebeeregulatory Tempo inteiro

Job Title: Clinical Operations SpecialistThe clinical operations specialist plays a vital role in ensuring the safety, efficiency, and compliance of pharmacovigilance systems.Main Responsibilities:Collaborating with cross-functional teams to gather requirements and implement solutions for pharmacovigilance systems and workflowsPartnering with regulatory teams and IT to enhance safety systems and ensure global compliance standards are metDocumenting business processes, data flows, and system functionalities related to adverse event reportingQualifications and Skills:Bachelor's degree in Life Sciences, Pharmacy, or ITIn-depth knowledge of pharmacovigilance processes and regulatory requirementsExperience working with safety systems like Argus, ArisG, and Veeva Vault SafetyBenefits and Requirements:Pursuing certification in pharmacovigilance is highly desirableExperienced in validation and user acceptance testing of PV systemsKey Phrases: Pharmacovigilance, Regulatory Compliance, Safety Operations, Clinical Operations Specialist



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