Senior Specialist, Regulatory & PV Network

Added
18 days ago
Location
Type
Full time
Salary
Salary not provided

Related skills

gcp project management audits pharmacovigilance regulatory

📋 Description

  • Act as Local Contact Person for Pharmacovigilance for the designated country
  • Lead regulatory deliverables and PV activities per established plans across projects of medium/high
  • Develop strategy and manage setup activities (PM Plan, SOPs, POAs, core documents)
  • Provide strategic input to clients and internal teams; address risks with preventive measures
  • Support audits/inspections and prepare monthly KPI reports
  • Prepare client invoices and review vendors’ project invoices

🎯 Requirements

  • Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent
  • Pharma or CRO/regulatory experience; knowledge of ICH GCP and/or GVP and local regs
  • PV training/experience; fluent in English; proficient in local language where based
  • Strong planning, organizational, and interpersonal skills; attention to detail

🎁 Benefits

  • Global pharmacovigilance environment
  • Collaborative, values-driven culture
  • Opportunity for professional growth within regulatory and PV networks
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