Our drug safety and pharmacovigilance team partners with clients to develop and implement pharmacovigilance strategies. We understand our clients’ commitment to product stewardship and their need for rigorous programs that meet regulatory requirements and protect patients. Mediclin enables life science organizations to implement effective domestic and global pharmacovigilance, clinical safety and risk management programs. Each software solution is fully compliant with international regulations supporting case management, report preparation, electronic submissions and benefit/risk management in accordance with international guidelines. Within the scope of contracted services the Pharmacovigilance team at Mediclin is competent to monitor safety and efficacy of investigational medicinal products and marketed drugs, to meet reporting obligations in line with worldwide regulatory requirements and thus contributing to the ongoing risk-benefit assessment.
Tasks handled by our pharmacovigilance team include
- Set up and maintenance of a global safety database
- Receiving, processing, archiving adverse events/reaction information
- Medical assessment of individual cases
- Contribution to risk signal detection
- Risk management strategy
- Ensure compliance with local and international requirements
- Safety reporting to Health Authorities and other parties
- MedDRA coding and coding convention strategies.
- Medical support for SAE reconciliation
- Preparation of written pharmacovigilance procedures (SOPs)
- Preparation of SAE case narratives
- Interim safety reports (on demand)
- Annual safety reports
- Periodic Safety Update Reports (PSUR)