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.
- 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.
- 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 email@example.com