Associate Director, Pharmacovigilance (pv) Operations

Nuvalent

Remote, United States
Base: $185,000 - $205,000 usd; bonus/equity: not s...
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8-10 years biotech/pharma experience
Vendor relationship management in safety
Icsr case processing and reporting expertise
** Nuvalent is seeking an Associate Director of Pharmacovigilance Operations to oversee vendor relationships and ensure compliance with safety processes in drug development. The role requires extensive experience in pharmacovigilance and operational safety within the biotech or pharmaceutical industry, with a focus on managing ICSR processing and data analysis. **

Job Summary

  • The role involves providing vendor oversight and review of ICSR processing while ensuring compliance with Safety processes and SOPs.
  • Candidates will manage relationships with safety vendors to ensure the effectiveness, quality, and compliance of all outsourced activities.
  • Nuvalent offers a comprehensive benefit package including medical, dental, vision insurance, 401(k), and generous paid time off.

Matching Summary

Match Score: 75

** Nuvalent is seeking an Associate Director of Pharmacovigilance Operations to oversee vendor relationships and ensure compliance with safety processes in drug development. The role requires extensive experience in pharmacovigilance and operational safety within the biotech or pharmaceutical industry, with a focus on managing ICSR processing and data analysis. **

Salary

Base: $185,000 - $205,000 USD; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), PTO

Skills & Requirements

Must-have

  • 8-10 years biotech/pharma experience
  • Vendor relationship management in safety
  • ICSR case processing and reporting expertise
  • Regulatory compliance with FDA EMA GVP ICH CIOMS
  • Safety database management and analysis

Nice-to-have

  • Strong communication and stakeholder influence skills
  • Experience in clinical development programs
  • Ability to work in a matrixed environment
  • Project management and prioritization capabilities
  • Knowledge of MedDRA coding

Key Requirements

  • Bachelor's degree in nursing, pharmacy, or related field
  • 8-10 years of experience in biotech or pharma
  • Direct experience managing external service providers
  • Strong knowledge of regulatory requirements (EMA GVP, FDA IND/NDA)
  • Proven knowledge of Good Documentation Practices and cGxPs

Work Rights

Not specified

Tailored Resume

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