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PV Operations Manager

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Country: United States State: Michigan City: Detroit Postal Code: 48202

Email: akakadekar@clynico.com Website: https://www.clynico.com

Industry: Pharmacovigilance Operations / CRO & Biopharma

Requirements & Experience:

  • Oversee day-to-day PV operations and workflows
  • Manage ICSR processing and reporting activities
  • Ensure compliance with global regulatory timelines
  • Lead and mentor PV operational teams
  • Coordinate with CROs and external vendors
  • Monitor KPIs, SLAs, and quality metrics
  • Support regulatory inspections and audits
  • Implement process improvements and automation
  • Manage resource planning and workload distribution
  • Report operational performance to senior leadership

Job Description:

  • Degree in Pharmacy, Life Sciences, or related discipline
  • 812 years pharmacovigilance experience
  • Strong operational leadership background
  • Experience managing large PV teams or vendors
  • Knowledge of FDA and EU GVP requirements
  • Audit and inspection management experience
  • Strong problem-solving and decision-making skills
  • Ability to manage multiple products and regions
  • Excellent communication and leadership skills
  • Continuous improvement and quality-focused mindset

Contract: Permenant

Employment Level: Intermediate

Shift: M-F 8 Hours

Hours: 40 hours

Facilty Name: Clynico Consulting Ltd

Facility Type: Office

Salary (Unit): $12,000/monthly ($144,000/yearly)

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Job ID:an35656

Job Type:Pharmacovigilance Operations Management

Tax Term:W2

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