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Senior Operations Specialist- Regulatory Reporting (R1048889) in Dublin, Ireland at IQVIA™

Date Posted: 5/4/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    5/4/2019
  • Job ID:
    R1048889

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

PURPOSE

Apply knowledge and expertise including complex decision-making activities to review, assess and process Lifecycle Safety data and information across all service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.

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 and against country specific regulations.
  • 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

  • In depth knowledge of Lifecycle safety processes and willingness and aptitude to learn new skills across Lifecycle safety service lines.
  • In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
  • Proven ability to meet strict deadlines; manage competing priorities.
  • Demonstrate effective project management and leadership skills.
  • Sound judgment; independent thinking and decision making skills.
  • Demonstrate a flexible and receptive approach to changing demands.
  • Proven ability to work independently and autonomously with policies and practices.
  • Effective mentoring and coaching skills.
  • Excellent attention to detail and accuracy maintaining consistently high quality standards.
  • Excellent organizational skills and time management skills.
  • Excellent written/verbal communication and report writing skills.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients.
  • Ability to work effectively on multiple projects simultaneously organize own workload and effectively manage competing priorities 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degree in a Health Science and 3 years’ experience of Lifecycle safety (Pharmacovigilance, CEVA, Medical Information, Safety Publishing, Risk Management etc) or equivalent combination of education, training and experience

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1048889