Drug Safety / Pharmacovigilance
Akos offers established full Drug Safety / Pharmacovigilance services. Each client is provided with a bespoke solution to meet their specific requirements, including both global and local projects from Phase 0 throughout the whole of the product life cycle.
Akos offers you
- Client-tailored SOPs and working practices to supplement our in-house procedures
- Customized Pharmacovigilance databases using our in-house Validated global safety database
- Comprehensive AE and SAE management (tracking, narratives, coding, follow-up)
- Medical Safety Assessment of individual case reports
- Preparation and submission of aggregate adverse event data reports
- Electronic Reporting to EMEA and European Competent Authorities
- Paper based individual case safety report submissions to Authorities, Ethics committees and Investigators
- Legacy data upload
- Responsible Person for EudraVigilance information
- EEA Qualified person for pharmacovigilance
- Local Qualified Person/Representatives where required
Akos Drug Safety/Pharmacovigilance service has extensive experience in offering solutions in:
Akos' experienced Drug Safety/Pharmacovigilance teams have a variety of Industry and Service backgrounds. We understand the challenges you encounter in a constant changing environment and we provide compliant solutions to meet your drug safety needs.
In recent years there has been an increased focus on Drug Safety and Pharmacovigilance, and this combined with more complicated regulatory requirements, means a complete and through knowledge is required to maintain compliance with world wide Drug Safety/Pharmacovigilance obligations. Akos offers an established global Drug Safety/Pharmacovigilance service; this can provide specific consultancy and assistance through to globally servicing the Pharmacovigilance requirements of a product throughout its development and marketing life cycle, to meet your Pharmacovigilance needs.