Roles in Pharmacovigilance Teams
At Med Communications, our team of pharmacovigilance experts can support your pharmacovigilance team through years of expertise and razor-sharp focus on critical functions such as:
- Review and gap analysis of your pharmacovigilance system and processes
- Preparation of pharmacovigilance system documentation, such as standard operating procedures, working instructions, handling guides and training plans
- Meticulously documenting and reporting of ICSRs from various sources
- Authoring clinical and postmarketing aggregate safety reports(PSUR, PBRER, PADER, DSUR, AddCO)
- Providing systematic safety risk management planning support
- Full safety signal evaluation and documentation in compliance with applicable guidelines
- Literature research, review and critical appraisal
Building on years of hands-on experience and through constant skill enhancement, we strive to provide our clients with pharmacovigilance systems that are both regulatory compliant and proportionate to their organization, ultimately improving patient’s lives.
Contact us to see how we can act as a your pharmacovigilance team or add to your pharmacovigilance team: 877-477-0977 or https://medcommunications.com/contact-us/
