Associate Director, PV Scientist

Position: The incumbent supports all aspects of safety science, medical surveillance, and risk management activities for Nurix Products. Works cross functionally with internal (i.e., Clinical Development, Clinical Operations, Regulatory Affairs, and Data Management) and external stakeholders to monitor and maintain the safety profile of all Nurix products.

Responsibilities:

• In collaboration with Nurix physicians, provides medical surveillance and risk management activities for all Nurix products
• Leads signal detection activities for a products emerging safety profile and presents safety data at monthly medical safety review meetings
• Author and compile pharmacovigilance aggregate reports (e.g., DSUR) for all Nurix compounds and ensures all safety documents are submitted according to regulatory requirements
• Supports the development of Investigators Brochure (IB) and analyze data for the RSI section of the IB
• Supports authoring of study protocols and ICF
• Participates in new study initiation to ensure PV requirements are met including but not limited to safety reporting, query resolution, SAE reconciliation, and safety reporting training.
• Represents PV at cross-functional meetings and additional activities to support clinical development programs
• Perform data analysis to evaluate safety signal and write up analysis results
• Analyze data and write responses to health authority queries
• Supports process improvement and cross functional initiatives for safety science including SOPs and procedural documents
• Performs QC on cases processed by vendor and provides feedback
• Provides safety reporting training to internal Nurix employees and contracted vendors
• Contributes to the development of safety management plans and other safety related plans as necessary.
• Participates in audit/inspection preparedness activities and serve as subject matter expert during regulatory inspections

 

Required Qualifications

Minimum 10 years’ experience in pharmaceutical industry and at least 7 years in PV/Safety Science

Bachelor’s degree in health-related discipline or equivalent (RN, R.Ph., Pharm D, or MD)

Experience with aggregate safety reporting (DSUR), safety surveillance, signal and/or risk management

Strong knowledge of US and International safety reporting regulations

Strong experience in case processing and QC of ICSR is required

Experience with the use of global safety database is required.

Experience leading safety data review meetings is required

Active participation in regulatory inspections and audits

Self-motivated, ability to take ownership of, and follow through with specific tasks

Ability to effectively communicate, collaborate, and excel in a fast-paced and rapidly growing department and organization

Highly organized with strong attention to details

Experience with clinical and post marketing safety activities

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