The tabs that appear in the navigation bar depend on your account permissions and your Admin’s custom configuration.
Note: Depending on your Admin’s configuration, your Vault’s object, field, and section labels, lifecycle states, and workflows may differ from the general information in all articles. Refer to your organization’s business processes for guidance.
For information on navigation items in all Safety Suite Vaults, see Navigate Safety Suite.
PSMF
Use the PSMF tab to:
- Manage PSMF documents, including organizing global and local documents in a binder structure and tracking document changes in a logbook.
- Access generated PSMF PDFs.
- Perform PSMF periodic reviews.
- Generate PSMF documents from reports.
Literature
Use the Literature tab to manage the literature review process, including creating Literature Reviews and their related Literature Articles, and creating Inbox Items from Literature Articles.
PVAs
Use the PVAs tab to manage Pharmacovigilance Agreements (PVAs), including PVA Relationships and open PVA Action Items, as well as activities required by multiple PVAs.
Risk Management
Use the Risk Management tab to manage core and local:
- Risk management plans (RMPs) and their associated documents
- Risk measures
- Implementation strategies
Signal Management
Vaults configured for signal management include the following tabs:
- Use the Safety Investigations tab to track, validate, and assess signals relevant to medicinal products.
- Use the Product-Event Combinations tab to create and track product-event combinations (PECs).
- Use the Reporting Periods tab to create and track reviews.