|Reference # :||19-10076||Title :||Pharmacovigilance Specialist II|
|Location :||Brisbane, CA|
|Position Type :||Contract|
|Experience Level :||Start Date / End Date :||09/16/2019 / 09/16/2020|
|Performs triage for all incoming cases (including the following clinical assessments: seriousness, listedness/labeledness, and causality)|
Determine follow up requirements and perform follow up for all case types
Performs review and assessment of the validity of literature abstracts and articles
Performs accurate data entry and narrative creation for all individual case safety reports
Participates as the PV representative in Project Team Meetings for assigned projects (including protocol and ICF review, development of SRPs, Safety Reporting presentations at Investigator Meeting and reconciliation activities)
Develop and maintain product and disease state knowledge for all Company products
Ensure departmental workflow processes and timelines are followed
Assure and maintain compliance with regulatory and local/global timelines
Minimum of 3-5 years Pharmacovigilance experience.
Previous experience with safety database application(s)
Thorough knowledge of medical terminology essential.
Strong knowledge of MedDRA
Knowledge of Pharmacovigilance and processes, knowledge of appropriate regulations and related timelines
Skill requirements: ability to work in a team environment, strong organization skills, detail oriented, meet tight deadlines, strong communication skills both verbal and written, demonstrate computer proficiency, demonstrated initiative and accountability.
Strong knowledge of internal medicine, epidemiology, physiology and pharmacology