The opportunity
To perform the case processing and related activities in alignment with Global data Management
How you’ll spend your day
Serious, and non-serious case processing experience of business partners, health authorities, social media, non-interventional studies, legal case processing, literature case processing experience, clinical trials, and PSP/MRP/IIS. In depth knowledge of various case processing conventions, scenarios and have processed variety of cases with the mix of Literature, business partner, spontaneous, health authority with achieving daily/monthly/yearly productivity.
End to end case processing experience including intake, triage, case processing, quality check and submissions and investigating and resolving E2B rejections with successful submission.
Supported for major health authorities’ Audit/inspections as presenter to auditors and submitted the auditors’ requests after through quality check.
Clarified all day-today case clarifications from various serious and non-serious cases (not limited to spontaneous, solicited, clinical trials, legal, social media, literature, non-interventional studies, clinical trials).
Involvement in SOP reviews and provided the changes with thorough review of ICH, GVP guidelines etc and worked as mentor in CAPA/deviations writing, investigating, monitoring, tracking until final completion.
Experienced in gap analysis and multiple stakeholders’ interaction for various projects in pharmacovigilance department.
Additionally, if you have experience in Literature monitoring, translation requests, search strategy building, quality check of literature activities, downloading source documents from various health authorities’ databases (not limited to Health Canada, EMA, MHRA) and other related activities.
Involvement in various data correction projects and cleanup projects in safety database.
Assist with mentoring and training activities in case processing team. Conduct sessions to educate the team on the existing and on predicted error trends for process improvements.
Ensure that quality data is analyzed for any trending and take steps for Quality improvement.
