Safety Aggreg Report Spec 1

5 days ago

Kolkata, West Bengal, India IQVIA Full time ₹ 12,00,000 - ₹ 18,00,000 per year

Job Overview

Serve as principal owner of the SARA deliverable and have responsiblility for completion of the deliverable in compliance with all applicable service level agreements.

Essential Functions

  • Act as primary author & or reviewer/QCer of SARA deliverables involving literature review projects.

  • Act as literature lead, back-up lead, reviewer/QCers to contribute in the conduct of ongoing literature safety surveillance for marketed and investigational products with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Author and/or contribute to literature deliverables for aggregate reports &/or signal management activities meeting strict regulatory timelines.

  • Interface with clients and other functional groups within Lifecycle Safety and other business units, Safety Operations (SO), and Information Technology (IT), as needed.

  • Participate in internal and external audits and inspections, as required.
  • Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
  • Read,acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion to maintain compliance 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, statement of work (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.
  • Support and/or contribute to technology / innovation activities.

Qualifications

  • Bachelor's Degree Bachelor's Degree Req

3-4 years of prior relevant experience in areas of literature surveillance. Pref

  • Equivalent combination of education, training and experience. Req
  • Good understanding of Standard Operating Procedures (SOPs) and work instructions applicable to the role. Intermediate
  • Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate
  • Good knowledge of medical terminology. Intermediate
  • Strong organizational skills and time management skills. Intermediate
  • Strong verbal/written communication skills. Intermediate
  • Self-motivated and flexible. Intermediate
  • Excellent attention to detail and accuracy. Intermediate
  • Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
  • Proven ability to multi-task, manage competing priorities and deadlines. Intermediate
  • Willingness and aptitude to learn new skills across all Lifecycle Safety service lines. Intermediate

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

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