Gurleen K. Bedi

WORK HISTORY

EDUCATION

SKILLS

ABOUT GURLEEN K. BEDI

I am a highly motivated, organized and detail oriented professional with an educational background of Master’s and Bachelor\'s in Pharmacy (Equivalency assessed by WES, Canada), with over 7 years of experience in Drug Safety/ Pharmacovigilance (PV) and Clinical Research. I am a dynamic and well-grounded professional with a passion for the advancement of healthcare industry. I consistently demonstrate a can-do attitude and embrace tough challenges with energy and enthusiasm. My on-the-job experience has awarded me a well-rounded skill set, including first-rate project management, excellent organizational skills, people skills, prioritizing work as per the dynamic environment of an organization, data entry, support inspection and audits as required, diligence in follow-up attempts ensuring case completion and documentation and archiving of all reported information and source documentation with thorough understanding of medical terminologies in the dynamic field of drug safety and clinical research. Skills and Experience-Skilled in Follow-up process, case report submissions, adverse event (AE) reporting, quality assurance and regulatory compliance for ICSRs (SUSAR, Clinical trials, Literature, Spontaneous and Solicited) in LSMV, ARGUS, SCEPTRE, ARISg and AgTracker database -Thorough understanding of ICH, GVP, GDP, GCP, GMP, Health Canada GVP and familiarity with Canada Vigilance-MedEffect Program and US FDA, TGA, MHRA-EMEA regulatory requirements -A proactive approach in data mining, retrieval, filing, analysis, structural problem-solving, team management and process improvement strategies including update and documentation of Internal PV policies, SOPs and work instructions as needed with proficiency in using MedDRA and WHO drug coding -Theoretical and practical understanding of titration, HPLC, GC, Polarimeter, UV/VIS and chromatography (TLC and column), In vitro and In vivo methods of test procedures -Working knowledge of MS Outlook, Word, Excel, PowerPoint and Adobe Acrobat; calibration system setup -Aptitude to work independently across multiple projects and work collaboratively with team members Please contact me to find out how I might contribute and add value to your organization.