Manager/Senior Manager, PV Operations

Location
San Francisco, CA, United States
Posted
Apr 13, 2021
Ref
5196561002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position

This remote position will see the incumbent support the implementation of PV Quality Management System (QMS). Responsible for managing and supporting pharmacovigilance (PV) vendor oversight activities and tracking key performance indicators (KPIs), compliance and quality of work performed for contracted PV services. The incumbent will also support safety database integration and data migration.

Job Responsibilities
  • Support the development and maintenance of PV department procedures in alignment with PV regulations.
  • Support regulatory compliance and inspection readiness of outsourced PV services.
  • Manage case processing activities by functioning as a subject matter expert in ICSR case processing of both clinical and spontaneous cases.
  • Oversee the QC of ICSRs and responds to ICSR related inquiries.
  • Provide support for expansion of business activities and ensures that PV processes are established, and all applicable regulatory requirements are met.
  • Maintain oversight of contracted PV services and training of PV Vendors and Nurix staff.
  • Participate in process improvement and vendor-client meetings
  • Support activities related to business integration including safety database integration, data migration, and integrating new assets or companies into Nurix system.
  • Participate in the development or revision of SOPs, work instructions, guidance documents and safety management plans (SMP)
  • Support the development of SDEAs or pharmacovigilance agreement with Nurix partners and vendors for specific obligations for safety data exchange and reporting.
  • Contribute to inspection readiness and support Health Authority inspections of Nurix's pharmacovigilance function.
  • May assist with managing PV budgets, MSAs and SOWs with PV vendors.
  • Oversee the collection and review of pharmacovigilance compliance metrics related to PV activities.

Required Qualifications
  • Bachelor's degree in healthcare related field required. RN, R.Ph., or Pharm D. degree highly preferred.
  • Minimum of 5 years' progressive experience in pharmacovigilance in a pharmaceutical, biotech or related environment.
  • In-depth knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
  • Experience with safety database implementation and data migration.
  • Knowledge of adverse event reporting and processing in a clinical trial and post marketing setting.
  • Experience monitoring health authority submissions and compliance.
  • Experience leading and contributing to process improvements, quality management system, inspection readiness, Health Authority audits, standardization of safety reports, SDEA/PVA/SMP, vendor management, etc.

Bonus Qualifications
  • Effective time management and organization skills
  • Ability to effectively communicate, collaborate, and deliver excellent work in a fast-paced, and rapidly growing department and organization.
  • Knowledge of MedDRA and WHO Drug dictionaries
  • Ability to work independently with minimal supervision
  • Vendor onboarding experience

Fit with Nurix Culture and Values
  • Strong team orientation; highly collaborative
  • Solutions and results-oriented focus
  • Hands-on approach; resourceful and open to diverse points of view

Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix's extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix's drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix's wholly owned pipeline comprises targeted protein degraders of Bruton's tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.