Pharmacovigilance Data Associate

5 days ago


London Area, United Kingdom EPM Scientific Full time

POSITION DETAILS

Title: Pharmacovigilance Data Associate

Upward Reporting: Head of Quality and Drug Safety

Position Type: Permanent, ongoing with a 6-month probation period

Location: London, UK

Hours: Regular working hours are Monday to Friday from 9.00am to 5.30pm, with two days office attendance and three days remote working.

Travel: Some international travel may be required


ABOUT THE COMPANY

A global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.


DESCRIPTION OF THE ROLE

  • Assist the safety team in handling safety data (including adverse events) in compliance with regulatory requirements and Company SOPs
  • Case processing
  • MedDRA coding of safety events to the current version as required
  • Data entry in the Pharmacovigilance Database
  • Maintain the Pharmacovigilance Database
  • Monitoring adverse events (AEs) arriving via EEDR
  • Produce safety data, in the required format for signal detection and for inclusion in periodic aggregate reports
  • Provide safety data, in the required format, to the regulatory department for submission to the regulatory authorities
  • Assist in the ongoing improvement of the pharmacovigilance system
  • ICSR and SUSAR reporting via EVWEB (upon training); Medical and Scientific Literature search


ESSENTIAL REQUIREMENTS FOR ROLE

  • Life science degree
  • Working knowledge of GVP guidelines
  • Working knowledge of ICH GCP guidelines
  • At least 3 years’ experience in pharmacovigilance compliance/quality fields
  • Excellent attention to detail
  • High level of computer literacy
  • Ability to plan, organise and follow up
  • Track and plan clinical activities to meet agreed timelines
  • Maintain a current awareness of pharmacovigilance requirements
  • Effective verbal and written communication in individual and group settings
  • Ability to create and maintain relationships with internal/external customers
  • Ability to work in a team environment
  • Problem-solving skills
  • Effective time management of multiple tasks
  • Inquisitive mind
  • European languages an advantage (German/Italian/French)


WHAT’S ON OFFER:

  • A competitive salary with benefits.
  • The chance to contribute and be part of a team whose work directly benefits healthcare and strives to improve people’s lives.
  • A real hands-on opportunity to gain a high degree of commercial exposure.
  • The chance to work alongside world-leading scientific experts.
  • Working with highly-talented and dedicated colleagues in a fast-growing company that combines a focus on cutting-edge science with commercial delivery.



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