The role will over see establishing the strategy, direction, and priorities of pharmacovigilance activities and will lead the Safety Team.
The company's location is near Middlesex and the role offers hybrid home /office based working
* Validate safety signals and lead safety signal assessments
* Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
* Prepare/review core and regional risk management plans including additional risk minimization measures
* Prepare/review safety sections of periodic aggregate reports
* Provide safety input to protocols, statistical analysis plans, and clinical study reports
* Prepare/review safety sections of new drug applications and other regulatory filings
* Serve as safety expert on Evidence Generation Team for assigned products
* Inspection Readiness
* MD qualification
Strong prior industry pharmacovigilance (PV) experience
Product safety in the bio/pharmaceutical industry or regulatory agency
Previous management and/or mentoring experience
Experience in the study/research and/or treatment of Oncology disease states
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