Experienced LCS professionals, Regulatory Reporting – Operations Specialist 2
- Experience Level
- Experienced (non-manager)
Regulatory Reporting – Operations Specialist 2
Use your scientific and Pharmacovigilance expertise to join the world’s leading comprehensive pharmaceutical safety services organization on a fast-growing team performing Regulatory Reporting submissions. Apply your expertise, including GVP and/or GCP knowledge, complex decision making and working towards strict deadlines to meet legislative timelines.
Be a part of a global team to help ensure the safety profile of a COVID-19 vaccine with opportunities to improve worldwide public health.
Roles and Responsibilities:
- Review, assess and perform quality control on expedited and periodic Lifecycle Safety data from both clinical trials and post marketing studies.
- Expedited reports are received from multiple sources including, but not limited to, solicited clinical trial reports, post marketing surveillance reports, spontaneous reports, literature reports and legal reports for drugs, devices, consumer healthcare, cosmetic and dietary products.
- Periodic reports include, but are not limited to, Development Safety Update Reports (DSURs), Periodic Benefit Risk Evaluation Report (PBRER) and Line Listings.
- Triage safety data to identify the seriousness, relatedness and expectedness of events and determine reportability of cases based on the combination of this information.
- Distribute data to Regulatory Authorities, Ethics Committees, investigator sites, customers, licensing partners (LPs) and marketing authorisation holders (MAHs) as appropriate based on approvals of clinical trials and authorisations for drugs to be placed on the markets in different territories.
- Adhere to International Conference on Harmonisation – Good Clinical Practice (ICH-GCP), Good Pharmacovigilance Practice (GVP) modules and country legislation to ensure submission of safety information is made by the required timelines and by the correct transmission method.
- Database all submissions and use information in databases to calculate metrics and generate status and compliance report on a monthly basis, or as required.
- Perform User Acceptance Testing (UAT) on new databases and assist in configuring databases with project specific information.
- Create and maintain project specific submission templates.
- Liaise with internal and external functional teams transnationally to facilitate submissions of both expedited and periodic reports.
- Review project files at defined time-points to ensure audit and inspection readiness.
- Identify non-efficient processing methods, highlight and document process improvements.
- Participate in pilot and time-in-motion studies to implement process changes.
- Mentor junior team members.
- Develop and roll-out project or process trainings as areas of expertise develop.
- Document quality issues on projects, identify and implement corrective actions and preventative actions where necessary.
- Contribute and help drive global initiatives such as process automation, quality, training and databasing legislation.
- Perform all tasks in accordance to GCP, GVP modules, Standard Operating Procedures (SOPs) and project specific requirements.
Required Knowledge, Skills and Abilities
- Working knowledge of Lifecycle Safety services. Familiarity with functionality of IQVIA Regulatory Database and Endpoint Tracking Database.
- Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
- Ability to meet strict deadlines; manage competing priorities and changing demands.
- Sound organization and time management skills.
- Ability to follow instructions/guidelines, work independently and on own initiative.
- Good attention to detail and accuracy and maintain high quality standards.
- Demonstrate good IT skills.
- Effective written and verbal communication skills.
- Ability to be flexible and receptive to changing process demands.
- Willingness and aptitude to learn new skills across Lifecycle Safety service lines.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Minimum Required Education and Experience
- Bachelor’s Degree in scientific or healthcare discipline.
- Must be Fluent in English
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning.
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.