Drug Safety Specialist

Recruiter
PAREXEL
Location
South East England
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Quality control of case reports, line listings, and tabulations.Develop Expedited Reporting Procedures.Maintain local drug safety reporting requirements.Provide advice in regulatory affairs.Perform registration with relevant authorities for electronic reporting on behalf of sponsor.Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)Submission of periodic safety reports (i.e. DSUR, ASR)Submission of safety reports to investigators via ISIS (International Safety Information System)Measure investigative site performance in conducting required tasks in ISIS.Tracking and filing of submission cases as required.Un-blinding of SUSARs, as required.Collect and review metrics for measuring reporting compliance.Work with Global PV Information Office for collection and organization of global PV requirements.QualificationsSkills; Experience in PV, at least 1-2 years of experience in safety reporting.Thorough understanding of PV regulations and has experience of working with EudraVigilance.Sound knowledge of drug safety and the drug development process.Knowledge of and ability to interpret and apply global safety regulations.Experience in data analysis and evaluation of safety data.Good presentation skills.Analytical and problem solving skills.Clear understanding of the regulatory submission process.Proficient in database/literature searches.Great interpersonal skills.Strong verbal / written communication skills.Excellent organizational and prioritization skills.Ability to work collaboratively and effectively in a team environment.Client focused approach to work.Experience with computer applications including database management and pharmacovigilance systems. Education:Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification/work experience

Similar jobs

Similar jobs