IQVIA

European Qualified Person for Pharmacovigilance (QPPV)

Company
IQVIA
Location
Dublin
Posted
15 Apr 2021
Closes
05 May 2021
Ref
R1192927
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

IQVIA is seeking a European Qualified Person for Pharmacovigilance (QPPV). This individual will report to the Senior Director Pharmacovigilance, Oversight and Analytics and will have broad compliance and execution responsibilities and system applicable in the European Union. Can be based from any EU country

Job Overview

  • Establishing, maintains and is legally responsible for the Marketing Authorization Holder’s pharmacovigilance system in the EU .

  • Essential Functions

  • Establishing and maintaining/managing the Marketing Authorization Holder’s pharmacovigilance system in compliance with EMA GVP modules.

  • Having an overview of the safety profiles and any emerging safety concerns in relation to the medicinal products for which the Marketing Authorization Holder holds authorizations

  • Respond fully and promptly to requests from Regulatory Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or post-authorization of safety studies of medicinal products.

  • Remaining up to date and aware of any changes in EU regulatory requirements

  • Ensuring the necessary mechanisms and regulatory measures adopted for safety reasons and as part of risk management plans are carried out across the EU

  • Ensuring that the conduct of pharmacovigilance and submission of all pharmacovigilance related documents are in accordance with the legal requirements and GVP modules.

  • Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data submitted to the competent authorities in Member States and the Agency.

  • Providing any other information relevant to the benefit risk evaluation to the competent authorities in Member States and the Agency.

  • Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).

  • Acting as a contact point for pharmacovigilance inspections

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Have documented experience in the following areas:

  • Case reporting or case medical review

  • PSUR generation/submission or medical review

  • Safety / signal review meetings

  • PV Project Management / PV Project Medical Advisor

  • Communication with regulatory authorities

  • Sound appreciation of post-marketing SOPs

  • Have completed training specific to post-marketing PV

  • Verify continuous self-improvement / training and be ‘up-to-speed’ with changing pharmacovigilance regulations and requirements

  • Demonstrate an understanding of the legal framework for pharmacovigilance in the EU and have knowledge of applicable ICH and CIOMS guidelines

  • Demonstrate capability to deal directly with regulatory authorities and undergo questioning by regulatory authority inspectors during statutory inspections

  • Appreciate how to maintain an overview of the safety profile of the product

  • Understand what may change the benefit/risk balance of a product

  • Possess an understanding of compliance and of quality management systems

  • Be willing to provide support to and maintain a robust overview of the activities of local QPs/ responsible persons both within and outside the EU

  • Be able to rapidly gain access to up-to-date product safety data at short notice 24/7 (this safety data must be available at one point in the EU)Be available to attend the monthly IQVIA QPPV meetings in person or by phone

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Possess a degree in medicine, pharmacy or a life science, and at least two years’ experience in post marketing pharmacovigilance. Must reside in an EU member state

PHYSICAL REQUIREMENTS

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech

  • Extensive use of keyboard requiring repetitive motion of fingers

  • Regular sitting for extended periods of time

  • Occasional travel

#LI-CA2

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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