Safety Operations Specialist 1

IQVIA•Durham, NC

About The Position

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. This role involves performing Pharmacovigilance activities, including collecting and tracking adverse events, determining event status, database entry, coding, and writing narratives. The specialist will ensure quality and productivity standards are met, maintain compliance with processes, and document training. They will also create, maintain, and track cases, identify quality issues, and collaborate with various functional teams and healthcare professionals to address project-related issues. The role may involve liaising with clients on case processing and mentoring new team members. Additionally, the specialist will attend project meetings, support department initiatives, and ensure 100% compliance with people practices and processes. Depending on project requirements, the role may include medical review of non-serious adverse events and adverse drug reactions, ensuring completeness and accuracy of data and communicating with team leads for corrections.

Requirements

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.
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

Nice To Haves

Intermediate

Responsibilities

Prioritize and complete assigned trainings on time.
Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
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.
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.
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.
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.
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.