Safety Operations Specialist 1

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 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
• In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.

Qualifications:

• Bachelor's Degree Scientific or healthcare discipline or allied life sciences
• Bachelors degree and up to 3 years experience or the equivalent combination of experience, training and education
• 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. Intermediate
• 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 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

IQVIA