Arrowhead Pharmaceuticals
Director, Safety Science
San Diego, California, United States · Director
Sponsorship not specified$240k-$260kDetected 18 days ago
AlgorithmsGCPData AnalysisData VisualizationExcelVendor ManagementClinical TrialsFDA RegulatoryPharmacovigilanceResearchAnimal StudiesLeadershipCollaborationPublic SpeakingOrganizational SkillsMicrosoft Office
About the role
- The Director, Safety Science provides leadership to other safety scientists and scientific support in managing the development, implementation and oversight of Arrowhead investigational products.
Responsibilities
- Lead a group of Safety Scientists across Arrowhead's Therapeutic Areas.
- Supervise the Safety Scientists activities and approve documents and deliverables.
- Performs routine signal detection, trend recognition in blinded and unblinded patterns for clinical trials and contribute to signal detection from the internal safety database and literature reports
- Lead and facilitate department meetings
Requirements
- Prior experience in Safety/Pharmacovigilance Operations
- Strong working knowledge of case management and Experience in using ARGUS or other safety databases.
- Experience in Pre marketing and post marketing Signal Detection and Safety Data Analytics is critical
- 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
- Strong working knowledge of ARGUS case management and processing
- experience in using ARGUS or other safety databases
- Experience with quality assurance and compliance for drug safety
- Experience with regulatory inspections and audits of service vendors/business partners would be helpful
- Proficiency in standard desktop software programs (Word, Excel, Outlook)
- Strong interpersonal skills with the ability to professionally interact with cross functional team members
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 DSUR, FDA IND Annual Report etc.
Apply directly at Arrowhead Pharmaceuticals →Create a free account for alerts like thisView Arrowhead Pharmaceuticals immigration profile
This listing is sourced directly from Arrowhead Pharmaceuticals's careers page and normalized into a canonical job model.