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Senior Pharmacovigilance Scientist
2 months ago
SRG is partnering with a leading global pharmaceutical company to find a highly skilled Senior Scientist to join their team.
This is an exciting opportunity for an enthusiastic scientist with relevant industrial experience to work on a 12-month contract in Stevenage, Hertfordshire.
The successful candidate will be responsible for conducting analysis of human biological samples using immunoassays while ensuring full compliance with GCP regulatory requirements.
Key Responsibilities:
- Conduct analysis of human biological samples using immunoassays while being fully compliant with GCP regulatory requirements
- Holding yourself accountable for delivering high-quality bioanalytical results and managing timelines
- Build effective relationships with various supported groups within and outside the department
- Work as part of the team to ensure day-to-day laboratory responsibilities are met (reviewing study plans/reports, QC checking colleagues' work, safety inspections, instrument maintenance, etc.)
- Partner with external companies and institutes to deliver laboratory solutions
- Drive innovation and actively contribute to process improvements (scientific, regulatory/quality)
Candidate Requirements:
- Graduate degree in biology, biochemistry, or pharmacology
- Experience running Bioanalytical or Biomarker assays, preferably in a GxP regulated environment, with a focus on good record keeping and data integrity
- Ability to effectively manage multiple priorities, communicate recommendations clearly, and enjoy working within a team
- Ability to present both written and oral communications to R&D stakeholders
- Understanding of regulatory aspects of human biological sample management, Good Clinical Practice (GCP)
- Experience in the method development and validation of immunoassays using one or more of the following; Gyrolab, MSD, Simoa, SMCxPRO, or ELISpot
- Experience of interacting with LabQA/regulatory inspectors
- Experience in tailoring bespoke biomarker assay validations to the context of use for the data
- Experience with automated liquid handling platforms (e.g.,)
