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SERVICES

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SERVICES

Local-QPPV & deputy

  • EU-QPPV and deputy

  • UK-QPPV and deputy

  • Local-QPPV and deputy

Quality System Management in Pharmacovigilance

  • Pharmacovigilance System Master File (PSMF)

  • Standard Operating Procedures (SOP)

  • Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEAs)

  • PV Compliance: Metric and KPIs

  • PV Audits Supporting during Health Agency inspections

Literature monitoring

  • Medical Literature Monitoring (MLM) service

  • Global Literature Monitoring in global databases (PubMed, EMBASE)

  • Local Literature Monitoring and assessment by experts in non-indexed scientific journals

ICSRs on marketed products

  • SAE/SUSAR during clinical trials

  • ICSR on market products

PV training

  • In house and online training

  • Annual and onboarding personnel training

  • Online training with tailor-made training courses

PV Regulatory Intelligence

Notification of updates to the latest      PV requirements implemented by governments and regulatory  authorities, interpretation of the    impact and implications.

CONTACT

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Contact Details

Phone: +34 644 827 805

Email: safety@expertspv.com

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