Associate Operations Specialist (Safety Operations/Case Processing) (Home Based)

** Candidate must be open to working overtime and weekend hours**

Job Overview
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.

Essential Functions
• To Prioritize and complete the assigned trainings on time.
• Process Safety data from various sources according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement including but not limited to, intake and tracking incoming  - Adverse Events(AE)/endpoint information
• determining initial/update status of incoming events
• database entry including coding AE, Products, Medical history and labs, writing narratives, and other project activities as per internal/ project timelines.
• Assess Lifecycle Safety data for reportability to relevant authorities and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local IQVIA offices to facilitate expedited reporting.
• Ensure to meet quality standards per project requirements. Identify quality problems, if any, and bring them to the attention of a senior team member.
• 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.
• 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.

Qualifications
• High School Diploma or equivalent Scientific or healthcare discipline or allied life sciences
• Bachelor's degree in life sciences or related field and up to 3 years of relevant 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.
• Basic 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 verbal/written communication skills.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• 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 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.
• Demonstration of IQVIA core values while doing daily tasks - Extensive use of keyboard requiring repetitive motion of fingers.
• 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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.