Senior PV Specialist
Good working knowledge of medical/drug coding process (MedDRA and WHO drug dictionary)
Proficient in processing of safety information of clinical trial, post marketing surveillance and medical devices
Perform quality review for expedited cases prior to delivery to the client as needed.
Ability to perform reconciliation of SAEs between safety database and clinical database according to defined processes, if needed.
Ability to prepare a Draft Safety Safety Management Plan (SMP)
Tracking and triage of case information for processing
Prioritize incoming AE/SAE/ER information for further processing and confirm receipt, as required.
Identify potential 7-Day and 15-Day Alerts
Assumes case ownership responsibility for non serious, spontaneous and or serious clinical trial domestic and foreign cases as applicable.
At least 1-2 years experience in the tasks and responsibilities performed by a Junior PVS
General knowledge of drug therapy, disease states, clinical research
Ability to maintain and protect client, patient and corporate confidentiality.
Sound working knowledge of regulatory reporting requirements and international regulations (EU, US ,Japan and Asia)
Ability to work in an environment of rapidly changing priorities and manage multiple client projects
Ability to review medical data from clinical trials and post-marketing experiences, as applicable.
Ability to organize and manage work to meet strict timelines
Ability to provide exceptional customer service and professional interactions with a varied customer base, as necessary.
Ability to work independently with high reliability and a high sense of responsibility