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Key Responsibilities:Gather and analyze business requirements for safety systems and processes.Collaborate with stakeholders to implement or enhance pharmacovigilance workflows.Document business processes, data flows, and system functionalities related to adverse event reporting.Maintain compliance with global regulatory standards.Support validation and testing of PV systems.Provide training and support to end-users on safety systems and processes.Work collaboratively with cross-functional teams including regulatory affairs, clinical operations, and IT.Below are the required skills and qualifications for the role:Required Skills and Qualifications:Bachelor's degree in a relevant field such as life sciences or computer science.In-depth knowledge of pharmacovigilance processes and regulations.Experience working with safety systems such as Argus, ArisG, Veeva Vault Safety.Strong analytical and problem-solving skills.Excellent communication and interpersonal abilities.Ability to work collaboratively in cross-functional teams.Below are the desirable skills for the role:Desirable Skills:Certification in pharmacovigilance.Experience with validation and user acceptance testing of PV systems.Below are the tools and technologies used in the role:Tools and Technologies:Hands-on experience with pharmacovigilance safety systems.Familiarity with adverse event reporting workflows and compliance processes.Understanding of global pharmacovigilance regulations.Ability to use documentation and reporting tools.
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