Job Overview
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.
Essential Functions
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information
• determine initial/update status of incoming events
• database entry
• coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
• 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, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.
• 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.
• Ensure compliance to all project related processes and activities.
• Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
• Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
• Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
• set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
• Establish and maintain effective team and project service operations communications
• effective feedback on project performance to junior members of team.
• Participate or Lead trainings across Safety process service offerings
• participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
• To demonstrate problem solving capabilities.
• Liaise with different functional team members and health care professionals
• To liaise with client in relation to details on day to day activities as needed.
Qualifications
• Bachelor's Degree Scientific or healthcare discipline or allied life sciences
• Bachelor's degree in life sciences 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 Safety Database and any other internal/Client 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 Microsoft Office and web-based applications.
• To demonstrate effective project management and leadership skills.
• Effective mentoring and coaching skills.
• Excellent verbal/written communication skills.
• Demonstrate Sound judgment and decision making skills.
• Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities.
• Ensure quality of deliverables according to the agreed terms.
• Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders.
• Support audit preparedness
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Amenable to work in Shifting Schedule
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at ***************
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