Responsibilities
Ensure consistent processes and efficient review of critical clinical/safety data
Review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure
Prepare aggregated data visualization and facilitate meetings related to review of safety data on study level
Contribute to study start-up activities according to the applicable process/procedures (ex. input to the applicable documents, tools set up)
Serve as a member of the Extended Study Team and report on TRISARC deliverables
Work with the study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation
Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate
Provide input into the process of setting automated patient narratives, if applicable
Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicable
Lead quality of own deliverables
Take on tasks as assigned by the Directors, Associate Directors Clinical Trial Safety
Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed
Education/Experience
Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields
Minimum 2+ years of experience in Pharmacovigilance / Drug Safety
Understanding of the clinical study and drug development process
Knowledge of ICH/GCP Guidelines
Knowledge of SAE reporting requirements
Experience using data review tools is preferred
Quality focus, analytical skills, and ability to concisely summarize large amounts of complex information
Proven ability to prioritize and manage multiple tasks with conflicting deadlines
Excellent time management
Very good interpersonal and communication skills
Team player, able to work individually
Ability and willingness to work cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas
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 .
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.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company creates intelligent connections to accelerate the development and commercialization of innovative medical treatments, helping to improve patient outcomes and population health worldwide. IQVIA specializes in managing clinical trials, including late-phase studies, non-interventional studies, and managed access programs, while also providing data management and healthcare professional reference data maintenance services. The company is committed to integrity in its hiring process and promotes a culture of diversity, inclusion, and belonging that empowers innovation in healthcare.
