1.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 safety 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 worldwide.
Participate/perform in training and certification activities for PV GDO.
Other activities that the Safety Data Specilaist can assume depending of the role:
Provide franchise 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.
Oversee redistribution of workload within franchise and across franchise with manager support to ensure reporting timelines are met.
Identify coordinator, team, franchise, training and/or processes related issues and escalate to PV liaison, PV trainer or DMC PV management as appropriate.
Actively participate and ensure effective communication with different roles in Global 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.
1. At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
1. Self-motivated, excellent in work planning and time management.
2. Fluent oral and written English skills.
3. Good sense and awareness of regulations and policies.
4. Able to work under pressure and in a changing environment with flexibility.
5. Good communication skills with the ability to communicate with both the technical and business areas.