Safety Associate & Operation Specialist 1/2
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.
• To Prioritize and complete the assigned trainings on time.
• 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
• determining initial/update status of incoming events
• database entry
• coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
• Ensure to meet quality standards per project requirements.
• Ensure to meet productivity and delivery standards per project requirements.
• To ensure compliance to all project related processes and activities.
• Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• To demonstrate problem solving capabilities.
• Liaise with different functional team members, e.g. project management, clinical, data management
• health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
• May liaise with client in relation to details on day to day case processing activities.
• To mentor new teams members, if assigned by the Manager.
• Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
• Perform other duties as assigned.
• Lead/ Support department Initiatives
• 100% compliance towards all people practices and processes
• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences Req
• Bachelor's degree in life sciences or related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience.
• r equivalent combination of education, training and experience.
• Good knowledge of medical terminology.
• Working knowledge of applicable Safety Database and any other internal/Client applications.
• Knowledge of applicable global, regional, local clinical research regulatory requirements.
• Excellent attention to detail and accuracy.
• maintain high quality standards.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong organizational skills and time management skills.
• Strong verbal/written communication skills.
• Self-motivated and flexible.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
• Ability to delegate to less experienced team members.
• Ability to be flexible and receptive to changing process demands.
• Willingness and aptitude to learn new skills across Safety service lines.
• 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.
• Ensure quality of deliverables according to the agreed terms.
• Demonstration of IQVIA core values while doing daily tasks - Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.
• Flexibility to operate in shifts.
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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