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