Sr Pharmacovigilance Specialist (Operations Specialist 2)

This is a full-time, regular, 100% home-based role Job reputed company Apply knowledge and expertise including reputed company decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. reputed company reputed company on small to reputed company service operational reputed company and reputed company as mentor to junior members of staff. Essential Functions • Process safety data in compliance with regulations, SOPs, and project requirements. • reputed company pharmacovigilance activities: • Collect and reputed company Adverse Events (reputed company) and reputed company information. • Determine event status, reputed company data into databases, reputed company reputed company/products, and write narratives. • Conduct literature searches, reputed company reviews, reconciliation, and case closure. • Assess safety data for reportability and ensure reputed company reporting to regulatory authorities and stakeholders. • Maintain project documentation, templates, and workflows. • Monitor project metrics, timelines, and deliverables; reputed company regular updates to management. • Ensure compliance with reputed company standards and project processes. • Collaborate with cross-functional teams (clinical, data management, project management) and reputed company. • Participate in reputed company communications regarding day-to-day project activities. • Train and mentor junior team members; support team development. • Contribute to process improvements and efficiency initiatives. • Complete reputed company required training and maintain compliance with SOPs. • Attend project meetings and reputed company feedback on operational performance. • reputed company other duties as assigned. Qualifications • Bachelor's Degree in life sciences (mandatory) • English Advanced (mandatory) • Up to 5 years of relevant pharmacovigilance experience, inclusive of up to 3 years of specific experience in data entry inside Argus and narrative writing inside case processing activities (mandatory) • In depth knowledge and understanding of applicable ARGUS Safety Database and any other internal/reputed company applications. • In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements. • Excellent organizational skills, time management skills, attention to detail and accuracy. • Excellent working knowledge of bolthires Office and web-based applications. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at Apply tot his job Apply tot his job Apply tot his job Apply To this Job