Operations Specialist 2
Descripción del trabajo
As an Operations Specialist 2 you will apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• Perform Pharmacovigilance activities including but not limited to, collecting and tracking incoming Adverse Events/endpoint information determining status of incoming events, database entry, coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities and coordinating translations.
• Perform activities related to adjudication as applicable.
• Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation.
• Liaise with manager for regulatory tracking requirements and electronic reporting.
• Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
• Ensure to meet quality, productivity and delivery standards per project requirements.
• Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
• Establish and maintain effective team and project service operations communications
• Participate or Lead trainings across Safety process service offerings.
• Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.
• Liaise with client in relation to details on day to day activities as needed.
• Contribute to achievement of departmental goals
• Bachelor's Degree in Life sciences, healthcare discipline or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience.
• Excellent knowledge of medical terminology.
• 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 Microsoft Office and web-based applications.
• Effective project management and leadership skills.
• Very good mentoring and coaching skills.
• Excellent verbal/written communication skills.
• Self-motivated, flexible, receptive to changing process demands.
• Willingness and aptitude to learn new skills across Safety service lines.
• Proven ability to work independently and autonomously with policies and practices.
• Proven ability to multi-task, meet strict deadlines, manage competing priorities and prioritize tasks.
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients.
• Ability to work as a Team Player, contribute and work towards achieving Team goals.
• Demonstrate Sound judgment and decision making skills.
• Ensure quality of deliverables according to the agreed terms.
• Ability to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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