Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
6
6
years of professional experience
Work History
Safety & Pharmacovigilance Specialist II
Syneos Health
02.2023 - Current
Managed multiple projects simultaneously while meeting tight deadlines and maintaining high-quality work standards in a fast-paced environment.
Primary role:
Handling Workflow management (WFM) for operational team. Managing allocation of cases amongst 200 associates (including Case Processing, Medical Reviewer and Quality Review users).
Prioritizing LTD and Regulatory due cases. Oversaw the suppression workflow and monitored translation workflow via Multi-Trans.
Actively involved in Leave planning and weekend working management. Publishing team productivity and quality metrics on daily basis.
Secondary Role:
Backup user for EudraVigilance workflow.
Handling Pre-intake activity for mailbox cases and Post-intake for rest cases.
Supported in pregnancy case processing team.
Oversaw adverse events case reporting and conducted follow-up.
Provided training for new pharmacovigilance team members, fostering a culture of continuous learning and improvement.
Developed innovative solutions for complex case processing challenges, enhancing overall efficiency within the department.
Initiated process improvement initiatives that resulted in reduced case processing times without compromising data quality or integrity.
Evaluated incoming case reports for completeness, accuracy, and consistency before entering them into the global safety database.
Responsible for maintaining clarification log for constant updates and conveying the same to the team.
Reconciliation of invalid reports.
Supported in PQ testing for Safety Case Tracker (SCT).
Performing daily tasks of manager in his/her absence.
Senior Safety Data Analyst
LabCorp
06.2018 - 11.2022
Developed training materials and facilitated workshops to enhance the knowledge and skills of other Safety Data Analysts.
.Data Entry (Case Processing) of ICSRs in Pharmacovigilance database. Entering source data in the database, Event Coding, Narrative writing.
Book in and Triaging of ICSRs.
Publishing team productivity and quality metrics on daily basis.
Reconciliations and review of invalid cases.
Responsible for replication and splitting of ICSRs.
Eudravigilance(Download,upload,validity check and monitoring to adhere to timelines).