Welcome
Pharmacovigilance Service
Dr. Syha Pharmaconsult offers a competent service for your local and/or global pharmacovigilance system.
We support you in set up, developing, operating, as well as analyzing and managing your pharmacovigilance system using our experience from over many years. You can rely on our tailored services provided at short notice in case of unforeseen staff shortages.
We continuously monitor requirements of national and international legislation for pharmacovigilance and can support you accordingly, both locally and globally.
Focus Pharmacovigilance
- Pharmacovigilance System Master File (set-up and update)
- Pharmacovigilance trainings (for all internal and external stakeholders)
- Quality management (including deviations and CAPAs)
- Process descriptions (SOPs and working instructions)
- Pharmacovigilance agreements (Safety Data Exchange Agreements)
- Communication with stakeholders
- Preparation of inspections, execution of audits (internal and at partner)
- Case assessment
- Signal management
- Writing of PSURs, DSURs und RMPs
- Implementing and monitoring of timely reporting to authorities (word wide, if required)
- Support with mandated trainings material and evaluate of its effectiveness
- Support during crises
- Service as EU QPPV and/or „Stufenplanbeauftragter“ for Germany
Contact
Jutta Syha PhD
- Biochemist
- 20 years experience in pharmacovigilance
- EU QPPV and „Stufenplanbeauftragte“ for Germany
- Heading Pharmacovigilance Operations and QPPV-Office
- Education and Professional Experience
Im Rosengärtchen 11
61440 Oberursel
Germany