Dhwani Banker

Sr Safety Specialist Safety Study Lead @Thermo Fisher Scientific

Ottawa, ON, CA

Manage safety work in clinical and post-marketing study cycle (start-end): Presentation of PV in Bid defense, Kick-of meeting and study quality audit to sponsor.• Prepare / review of safety management plan (SMP), expedited safety reporting plan (ESRP), Data validation manual (DVM) and Electronic Data Capture (EDC) check specification, project implementation checklist, monthly Key Performance Indicator (KPI) matrix, SAE reconciliation report to reconcile SAEs between clinical and safety database, RAVE PVG account maintenance. Communicate with safety reporting submission team for expedited report submission set-up. Liaison with clinical trial and global project manager for study start-up, maintenance and close-out updates.• Review and provide PV input to all core clinical documents including protocols, IBs, ICFs, and CSRs; safety aggregate reports including DSURs, PSURs, RMPs.• Drug safety database (ARISg, ARGUS) set-up, case data entry, QC, MedDRA coding and database maintenance.• Coordinates and leads preparation and attendance in client audits/inspections.• Key point of contact for client / sponsor. Prepares and leads operational calls with clients.• Maintains effective communication and coordination with other functional groups concerning project topics/issues.• Monitors, evaluates, and proposes mitigation strategies surrounding risk to PV project deliverables.• Provide safety science and pharmacovigilance subject matter expertise for regulatory responses, on program and study teams as well as other cross-functional platforms throughout the company.• Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation.• Accountable for project financial stewardship and negotiates options with the sponsor for various increases in scope of work to drive healthy gross profit and revenue margins.

Gujarat University

Bachlore of Pharmacy

Shri Sarvajanik Pharmacy College, Mehsana

Master of Pharmacy