Scientific Compliance Expert

1 day ago


Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full time

About Ethypharm:

We are a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive impact on society and the environment.

The Opportunity:

We are seeking a highly skilled Scientific Compliance Expert to support our UK pharmacovigilance department in overseeing the safety profile of products approved in the UK and marketed globally. As part of our team, you will perform a combination of scientific and compliance-related activities, including authoring aggregate safety reports, responding to requests from regulatory authorities, and reviewing changes to regulatory lists.

Responsibilities:

  • Authoring activities: Perform literature reviews, author aggregate safety reports, respond to requests from regulatory authorities, and review changes to regulatory lists.
  • Downstream activities: Lead Risk Management Plan work-sharing meetings, notify business partners and regulatory authorities, create risk minimization materials, and implement additional pharmacovigilance and risk minimization activities.
  • Interfacing activities: Provide input into quality, regulatory, and commercial matters, support new product implementation projects, and maintain safety variation trackers.

Requirements:

  • Minimum 5 years of experience in pharmacovigilance and compliance within the pharmaceutical industry.
  • Broad PV experience with a good understanding of GVP modules and local UK regulations.
  • Excellent communication skills, problem-solving ability, adaptability, flexibility, self-motivation, and results-orientation.

Estimated Salary: £70,000 - £85,000 per annum, depending on experience.



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