Associate Medical Safety Director - (1807890) in Buenos Aires, AR at IQVIA™

Date Posted: 7/3/2018

Job Snapshot

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.

Description

 
Major duties and responsibilities:
  • Provides Pharmacovigilance (PV) expertise for assigned products
  • Maintain PV expertise, and understanding of international safety regulations and guidelines
  • Provide and maintain PV and risk management expertise to internal and external customers
  • Maintain knowledge of product, product environment and recent literature
  • Communicate and represent PV data evaluation, interpretation and summary or conclusions as relevant
  • Responsible for signal detection and analysis
  • Review, prepare, and/or contribute to responses to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners 
  • Manage product safety alerts, as needed
  • Identify and implement proactive safety analysis strategies to further define the safety profile for
  • Provide proactive risk assessment
  • Document, coordinate, review and validate Periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report, Health Hazard Evaluation
  • Lead the preparation of Clinical Overview to support labelling changes
  • Lead the Safety part of the Company Core Safety Information (CCSI) creation and up
 

Job Requirements

Skills and Education:
  • MD Degree. Board Certified/Board eligible
  • Minimum 3 years of total experience in international Pharmacovigilance or equivalent relevant industry experience with relevant clinical experience considered.
  • Excellent clinical judgment
  • Capability to synthesize and critically analyze data from multiple sources
  • Ability to communicate complex clinical issues and analysis orally, including formal presentations,
  • and in writing
  • Able to develop and document sound risk assessment
  • Demonstrates initiative and capacity to work under pressure
  • Demonstrates leadership within cross-functional team environment
  • Excellent teamwork and interpersonal skills are required
  • Fluent in English (written and spoken).
 

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: 1807890