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Senior Pharmacovigilance Scientist
2 months ago
SRG is partnering with a global pharmaceutical company to find a Senior Scientist to join their team. This is an exciting opportunity for an enthusiastic scientist with relevant industrial experience.
Key Responsibilities:- Conduct analysis of human biological samples using immunoassays while ensuring compliance with GCP regulatory requirements.
- Deliver high-quality bioanalytical results and manage timelines effectively.
- 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, including reviewing study plans and reports, QC checking colleagues' work, safety inspections, and instrument maintenance.
- Partner with external companies and institutes to deliver laboratory solutions.
- Drive innovation and contribute to process improvements in scientific, regulatory, and quality areas.
- Graduate degree in biology, biochemistry, or pharmacology.
- Experience running Bioanalytical or Biomarker assays 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 work within a team.
- Ability to present written and oral communications to R&D stakeholders.
- Understanding of regulatory aspects of human biological sample management and Good Clinical Practice (GCP).
- Experience in method development and validation of immunoassays using Gyrolab, MSD, Simoa, SMCxPRO, or ELISpot.
- Experience 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.
This is an exciting opportunity for an enthusiastic scientist with relevant industrial experience. If you are a motivated and detail-oriented individual with a passion for bioanalytical research, we encourage you to apply.
