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Lead Safety Evaluation & Risk Management Scientist

  • Location

    Wiltshire, England

  • Sector:

    Pharmacovigilance

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    PV101_1650961229

  • Published:

    27 days ago

  • Consultant:

    Matt Thomas

Job title: Lead Safety Evaluation & Risk Management Scientist

A globally recognised engineering company with a new focus in consumer healthcare products are seeking a Lead Safety Evaluation & Risk Management Scientist. This role will join a new medical & clinical affairs function with a clear focus on innovation and research. This role is office-based in Wiltshire.

Responsibilities:

  • Participate in project meetings & providing SERM expertise including requirements and submission documents. As part of a multifunctional project team, contributing to the safety assessment of current & future innovation and research & development within the portfolio.
  • Following product launch, to contribute to the preparation & review of periodic reports (e.g. PSUR, EU Annual Safety Report, DSUR).
  • Review & provide safety content, as needed, for key study-related documents e.g. Investigator's Brochure, Informed Consent Forms, Safety Statements, Clinical Evaluations etc.
  • Contribute to analysis of safety data from on-going & completed clinical trials & presentation in Clinical Study Reports.
  • Perform/ provide oversight of safety review of individual safety reports from clinical trials or post-marketing sources.

Requirements:

  • Minimum of 5years' experience in Global Safety Risk Management, Clinical Safety, Pharmacovigilance or Risk Management.
  • Minimum of 5 years' experience in the pharmaceutical, medical device or cosmetic sector.
  • Proven SERM experience preferably within a medical device company)
  • Experience with toxicological assessments with Cosmetics and Medical Devices
  • Knowledge and good understanding of ICH GCP guidelines, industry-specific regulatory processes, and associated governance, including medical devices (i.e. ISO14155, ISO10993, ISO14971).
  • Knowledge and understanding of the regulatory process and associated governance of medical devices.
  • Experience of US FDA regulations advantageous.

Salary and benefits:

A highly competitive annual salary and wider benefits package is on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk