Arrowhead Pharmaceuticals
Senior Medical Scientist
San Diego, California, United States · Senior
Sponsorship not specified$185k-$210kDetected 15 hours ago
AlgorithmsGCPData AnalysisData VisualizationFDA RegulatoryPharmacovigilanceResearchAnimal Studies
About the role
- This role is base onsite 5x a week at Arrowhead's Research & Development site in San Diego, CA.
Responsibilities
- Performs routine signal detection, identifies and evaluate safety signals
- Develop and update of Safety Surveillance Plans for assigned products
- Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports, Company Core Data Sheet, Investigators Brochure and Risk Management Plan
- Support activities associated with launching a filing for the BLA/NDA or global marketing
Requirements
- 8 years in the pharmaceutical industry or CRO
- Experience in Signal Detection and Safety Data Analytics
- Strong working knowledge of FDA and international adverse event reporting regulations {ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulations
- experience in using ARGUS or other safety databases
- Strong interpersonal skills with the ability to professionally interact with cross functional team members
- Experience in the cardiometabolic and/or rare disease space.
- Candidates must have current, valid authorization to work in the country where this role is located.
Skills
- Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
- Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
Compensation
- Prepare periodic aggregate safety reports including PSUR, DSUR, FDA IND Annual Report etc.
Benefits
- Medical Review Responsibilities
- Perform Medical Review on SAE/SUSAR if applicable
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This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.