PV Scientist (R1091220) in Bangalore, India at IQVIA™

Date Posted: 8/2/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    8/2/2019
  • Job ID:
    R1091220

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Purpose:

Be a subject matter expert, conduct reviews, provide input and feedback in the areas of aggregate reporting, signal management and benefit-risk management 

Responsibilities:
Provide strategic input and review of applicable sections of the PBRER and DSUR to ensure that aggregate data analyses is consistent with overall product safety profile 
Manage ongoing core signal detection activities; Support the preparation and maintenance of safety sections of the Company Core Data Sheet 
Coordinates and authors responses to regulatory agencies or responses to inquiries from internal or external stakeholders 
Core member of the Safety Management Team, including setting agenda, producing necessary data outputs, requesting contribution of all functions, preparing slide presentations, facilitating discussions & documenting conclusions. 
Provide safety content for new drug applications and other regulatory filings including review of the safety and support to GSO for benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation 

Experience:
Required 6 years with relevant experience (including industry experience) with a working knowledge of drug safety and risk management, and understanding of drug development, knowledge of regulatory guidelines and medical coding (i.e. MedDRA). 
SARA experience of 3 years
ICSR experience is required or atleast understanding and exposure
 Knowledge of common data processing software (i.e., Excel, PowerPoint, Word) and database systems 
Fluent in English 
 

Join Us

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.



Job ID: R1091220