Senior Safety Scientist - (R1047147) in Dublin, IE at IQVIA™

Date Posted: 11/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Dublin, IE
  • Experience:
    3 to 4 years
  • Date Posted:
    11/2/2018
  • Job ID:
    R1047147

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 for Safety Aggregate Report and Analytics (SARA) Centre deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
 
RESPONSIBILITIES
  • Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements.
  • Lead, author and finalize aggregate reports, including but not limited to PBRERs, DSURs, PADERs, RMPs, ACOs, and six monthly line listings; author responses to regulatory agency/PRAC inquiries, as required.
  • Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
  • Conduct/Lead signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked.
  • Interface with other functional groups within Lifecycle Safety and other business units, such as Regulatory Affairs, RWLP, Medical Writing, Clinical Research, Quality, and Information Technology, as needed.
  • Participate in internal and external audits, as required.
  • Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
  • Read, acknowledge and adhere to all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
  • Serve as the interface between the global project lead and the working team; conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
  • Provide mentorship and training to less experienced resources.
  • Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns; participate in project review meetings with management; communicate and document project issues to project team members and department management in a timely manner.


Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Excellent knowledge of Lifecycle Safety services and processes; willingness and aptitude to learn new skills across Lifecycle Safety service lines.
  • In depth knowledge and understanding of applicable global, regional, local regulatory requirements; i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.
  • Proven ability to meet strict deadlines; manage competing priorities and ability to be flexible and receptive to changing demands.
  • Excellent organizational skills and time management skills.
  • Proven ability to follow instructions/guidelines, work independently and on own initiative.
  • Excellent attention to detail and accuracy maintaining consistently high quality standards.
  • Excellent written/verbal communication and report writing skills.
  • Sound judgment; independent thinking and decision making skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Effective mentoring and coaching skills.
  • Good understanding of operational metrics, productivity and initiatives.
  • Demonstrate effective project management and leadership skills.
 MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s Degree or educational equivalent in a Scientific or Healthcare discipline and 3-4 years’ of drug safety or 2 years’ experience in aggregate reporting 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: R1047147