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Pharmacovigilance

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A Full Suite of PV Services at Your Disposal

Tigermed’s pharmacovigilance experts have a sound understanding of global regulations and requirements. Combined with industry experience, they are well-suited to provide our clients access to a wide range of services. Being consistently quality-driven, globally oriented, and customer-focused has led to a proven track record of meeting or exceeding clients’ expectations.

 

Pharmacovigilance Operations for Clinical Trials

One-stop project management:

  • PV system introduction
  • Preparation: Review protocol; Review investigator branch; Review CRF; Draft safety management plan; database setup
  • Case management
  • Meetings such as safety review committee
  • Draft/Review DSUR
  • Draft/Review risk management plan

 

Pharmacovigilance Operations for Post Marketing

  • Call center
  • Literature search
  • Case management, including cases from Health Authority and oversea serious adverse reaction cases
  • Draft/Review PSUR
  • Draft Annual Report
  • Signal detection
  • Draft/Review risk management plan

 

Support Services Outsourcing

  • Pharmacovigilance Audits
  • Training
  • Pharmacovigilance system outsourcing

 

Data Security

Tigermed’s SOP and relevant guides have been updated according to EU General Data Protection Regulation.

  • Data confidentiality
  • Data integrity
  • Data availability and resilience

Procedures for regular testing, assessment and evaluation control objectives.

 

Project Experience

*As of Q1 2020

Customers

Projects