Authoring of Pharmacovigilance agreements and Safety Management Plan (SMP)

 Enter Pharmacovigilance agreements and Safety Management Plan (SMP) data into the Veeva (Business Development Lifecycle Management [BDLM]) database (VeeVa Vault)

Perform a random sample of the BDLM data against the information in the source documents of the PV Agreements

Understand the data updates being made to BDLM and information in BDLM metadata fields are accurate.

Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers. 

Safety Management Plan

Pharmacovigilance agreements

Veeva