IQVIA
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.
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
Life Sciences Degree
Excellent written and verbal skills in French (C2/native) and English (min. C1)
3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance 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.
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.
Flexibility to operate in shifts.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.