Pharmacovigilance Executive

Attribute Value
Type Full time
Salary Competitive
Closing date 31 August 2018
Reference RG134HP

A bit about us

Regulis is a specialist consultancy company, formed in 2001, providing global Pharmacovigilance, Regulatory Affairs and Quality Assurance services.  The company is built around a growing permanent team based in Tring, Hertfordshire, UK supplemented by an established network of consultants to deliver high quality, customer-focussed solutions.

We have an enviable reputation for providing high quality consultancy and support with a customer-focused approach that is second to none.

Our clients include large, medium and small pharmaceutical companies located across the world.

About the role

The Pharmacovigilance Executive holds an important position within the company and specifically, the Pharmacovigilance team.  This role offers the opportunity to act with a significant degree of independence to fulfil and execute a variety of project responsibilities.  Working closely with and providing support to the EU QPPV and Drug Safety Physician, you will ensure that Pharmacovigilance requirements for clinical trials and post-marketing are being adhered to.

This is an excellent opportunity for an independent, self-motivated and driven Pharmacovigilance professional to join a company that will not only provide you with a wide variety of experience in Pharmacovigilance projects, it will also give you all the support you need to grow and develop in the role.

Key highlights

  • The successful candidate will be responsible for and gain exposure to many different aspects of Pharmacovigilance
  • Represent the Pharmacovigilance department to clients, other third parties and internally within the company
  • Review, analyse and interpret safety data authoring and/or providing input to safety-related documents, such as periodic reports.
  • To be the primary PV contact for assigned projects to ensure activities and timelines are met and compliant with the regulations
  • Play a significant role in helping the department grow
  • Provide technical advice and guidance to clients and colleagues as required.

Your profile

  • Life sciences or Pharmacy Degree/Nursing qualification
  • 2 years PV experience in a Pharma company or CRO Safety Department, either Clinical Trial Safety or Post-Marketing Pharmacovigilance
  • Experience with Safety Databases and ICSR data entry
  • Familiarity and understanding of current EU PV regulations – US/FDA regulations and requirements would be an advantage
  • Experience of E2B electronic reporting would also be an advantage

What we offer

  • A competitive salary and benefits package
  • Modern newly refurbished office in a town centre location with parking facilities
  • Ongoing training and support
  • The chance to be part of an award winning consultancy that will help you to grow and build on your current experience aligning your career goals and aspirations with that of the company
  • A strong team working ethos with regular events organised.

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