Data Safety Associate

2 weeks ago


London, Greater London, United Kingdom EPM Scientific Full time
Job Description

EPM Scientific is a global leader in pharmacovigilance services, and we are seeking a highly skilled Data Safety Associate to join our team. In this role, you will be responsible for assisting the safety team in handling safety data, including adverse events, in compliance with regulatory requirements and company SOPs.

Responsibilities:

  • Case processing and MedDRA coding of safety events.
  • Data entry in the pharmacovigilance database and maintenance of the database.
  • Monitoring adverse events arriving via EEDR and producing safety data for signal detection and periodic aggregate reports.
  • Providing safety data to the regulatory department for submission to regulatory authorities.

Requirements:

  • Life science degree
  • Working knowledge of GVP guidelines and ICH GCP guidelines
  • At least 3 years' experience in pharmacovigilance compliance/quality fields
  • Excellent attention to detail and high level of computer literacy

Salary and Benefits:

  • A competitive salary of £50,000-£70,000 per annum, depending on experience.
  • The opportunity to work with a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders.
  • A dynamic and fast-growing company that combines a focus on cutting-edge science with commercial delivery.


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