His / Her tasks depend on the Process / role assigned : Registry and Case Processing, Junior PV Lead, Reviewer.
Perform registry and case assignment tasks as needed.
Perform data entry / review of all adverse experience information received and processed within internal database within the established timeframes.
Through daily case prioritization activities, reports are completed within the established timeframes to ensure compliance with internal, business partner, and regulatory agency reporting requirements.
Participate / perform in training and certification activities for JPV.
Other activities that the Safety Data Specilaist can assume depending of the role :
Provide team support by ensuring the appropriate resources such as SOPs and product / protocol guidelines are available and routinely updated to ensure the quality of reports.
Identify coordinator, team, training and / or processes related issues and escalate to JPV liaison, JPV trainer or DMC JPV management as appropriate.
Actively participate and ensure effective communication with different roles in Japan PV Safety, DMCs and other areas.
Perform case review of adverse experience information within the established timeframes to be compliant with internal, business partner, and regulatory agency reporting requirements worldwide.
Assist managers with reviewing individual coordinator report quality.