The Pharmacovigilance Specialist (PVS) primary responsibility is SAE case management. This includes but is not limited to: initial case disposition, confirmation of case disposition with Medical Monitor (MM)/Safety Physician PV (SP PV), MM, receipt of adverse event data, data entry, source document data extraction, draft narrative development, follow-up management and reporting according to regulatory requirements.
All activities will be in accordance with Clinipace and/or client SOPs, ICH Guidelines and local regulatory requirements.
Job Duties and Responsibilities:
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.
Consults with multiple stakeholders (e.g. the sponsor / medical monitor / pharmacovigilance physician) to decide on action and/or additional steps to provide complete narratives to the sponsor.
Handling of safety information according to given processes and procedures, by CPWW and/or client SOPs, WPs and Guidelines
Perform expedited reporting according to project requirements
Possess general working knowledge of PV regulatory frame work
Supervisory Responsibilities: None
Degree in life science or nursing/pharmacy qualification or other advanced or equivalent appropriate healthcare or pharmaceutical industry experience or education, e.g. laboratory experience.
Medical Documentalist, Medical Documentation Assistant, Nurse with extensive clinical experience or life science degree (e.g. natural scientist with a degree in biology, pharmaceutical medicine of similar speciality) preferred.
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.
Use of MS Office products to a competent standard – Word, Excel, PowerPoint
Ability to work independently with high reliability and a high sense of responsibility
Ability to work as a member of a team and possession of confident communication skills both written and verbal.
Ability to communicate in English (both written and verbal)
Willingness to provide guidance and training to less experienced staff
Willingness for continous on the job training and qualitfications measures
Ability to work with careful attention to details
Up to 10 % travel, as needed, for project team meetings
Client presentations and other professional meetings/conferences as needed
Works from home depending on the arrangement
Ability to work remotely
The company will not accept unsolicited resumes from third party vendors.