Pharmacovigilance operations Manager

Immunomeinc

Bothell, United States
**
Safety case management oversight
Vendor and cro management
Fda ema ich cioms compliance
** Immunome is seeking a Pharmacovigilance Operations Manager to oversee global safety operations for its clinical-stage oncology programs. The ideal candidate will manage vendor relationships, ensure regulatory compliance, and drive operational excellence in safety reporting. **

Job Summary

  • The Pharmacovigilance Operations Manager is responsible for managing day-to-day global safety operations across Immunome's clinical stage oncology programs as well as commercial products.
  • This role oversees case management activities conducted by external safety vendors and ensures timely and compliant safety reporting in alignment with global regulatory requirements.
  • The position requires an adaptable professional who can maintain inspection-ready safety systems and drive operational excellence across all PV workflows.

Matching Summary

Match Score: 75

** Immunome is seeking a Pharmacovigilance Operations Manager to oversee global safety operations for its clinical-stage oncology programs. The ideal candidate will manage vendor relationships, ensure regulatory compliance, and drive operational excellence in safety reporting. **

Skills & Requirements

Must-have

  • Safety case management oversight
  • Vendor and CRO management
  • FDA EMA ICH CIOMS compliance
  • MedDRA coding validation
  • Regulatory submission support

Nice-to-have

  • Adaptable organizational skills
  • Cross-functional communication
  • Inspection ready systems
  • Operational excellence drive

Key Requirements

  • Experience managing external safety vendors
  • Knowledge of FDA EMA ICH regulations
  • Background in oncology safety operations

Work Rights

Not specified

Tailored Resume

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