Pharmacovigilance Operations Manager

Added
2 minutes ago
Type
Full time
Salary
Salary not provided

Related skills

pharmacovigilance argus mdr ich-gcp gvp

πŸ“‹ Description

  • Leads global Patient Safety Ops and safety surveillance projects.
  • Partners with Clinical Development, Regulatory, Medical Info, Quality, and vendors.
  • Ensures compliance with ICH-GCP, regulatory requirements, and SOPs.
  • Maintains inspection-ready PV processes and documentation.
  • Drives continuous process improvement and quality metrics.

🎯 Requirements

  • Master's in Life Sciences or related; 6–8+ yrs PV exp, or Bachelor's 8+ yrs.
  • Progressive experience in pharma/biotech/medical device environments.
  • End-to-end case processing and ICSR/MDR lifecycle.
  • Safety databases (Argus) and signal detection.
  • Global GVP regulations and ICH guidelines knowledge.
  • Strong cross-functional collaboration and communication.

🎁 Benefits

  • Competitive base salary plus annual bonus.
  • Flexible PTO, holidays, and parental leave.
  • Healthcare, HSA match, 401k match, insurance.
  • Pet insurance and wellness discounts.
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