Pharmacovigilance
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.