• Multiple Asia Pacific and Global phase I-III studies using Veeva Vault/Argus safety DB and end to end case processing, tracking and reporting in Veeva Vault safety and Argus• Writing Global Safety Management Plans (SMP) and Development Safety Update Report (DSUR)• Detailed case processing activities including generation of safety narratives, CIOMS and Medwatch reports• Quality review of case reports• Determine and perform appropriate case follow-up; review and maintain project-specific safety tracker including expedited and periodic reports submission information• Reconciliation of SAE data against clinical databases• Timely review and distribution of project-specific Serious Adverse Events (SAE) to project teams• Communication with investigators regarding adherence to safety reporting rules• Attend and present at study kick off meeting and conduct CRA training• Configuring of applicable safety database with study-specific information• Supervise and guide new team members

• Taking orders and counselling customers nationwide over the phone, feedback was rewarding• Dispensing scripts and tailor made nutritional formulas on the PK Compounder• Creation and checking of batch worksheets• Checking orders and reassuring qualities before shipment to customers• Liaising with doctors, nutritionists and other health professionals to deliver innovative treatment for patients with different needs• Compounding a variety of products (e.g. nasal sprays, capsules, troches, transdermal multivitamin creams, oral drops, suspensions and suppositories etc) in pharmaceutical compounding laboratory• Assisting in product recall when required• Writing consumer information sheet of compounded medications and supplements• Helping out at national health conferences

▪ Timely distribution of project-specific Serious Adverse Event (SAE) and Immediately Reportable Adverse Events (IRAE) reports to project teams ▪ Review of incoming SAE and IRAE reports, drafting narratives.▪ Maintenance and timely update of the company’s project-specific SAE distribution lists ▪ Review of project-specific SAE trackers maintained by PSI project teams with focus on their timely update ▪ A contact point for Safety Desk and clinical project teams regarding SAE and IRAE reports flow and filing ▪ Interaction with IT personnel pertaining to safety line maintenance ▪ Communication with investigators regarding adherence to safety reporting rules ▪ Maintenance of Project safety files, and tracker in an orderly manner ▪ Generate CIOMS/MedWatch report using ARISg▪ QC CIOMS/MedWatch report, liaise with Study Sponsor and Medical Monitor▪ Overview the pharmacovigilance aspect of clinical trial studies▪ Draft Safety Management Plans, team SOP

Research project: drug-drug interaction potential of tyrosine kinase inhibitors used in cancer therapySupervisor: Prof.Michael MurrayProject description: Tyrosine kinase inhibitors (TKI) are a new class of anti-cancer agents that have revolutionalised the treatment of a range of cancers. Although TKIs have been extremely successful, they are associated with serious adverse drug-drug interactions and toxicities in some patients. Cytochrome P450 (CYP) enzyme inhibition is a major potential mechanism underlying pharmacokinetic drug interactions with TKIs. In the present study, 18 TKIs were assessed for the capacity to inhibit hepatic drug oxidations mediated by major CYP enzymes in human liver microsomes. The CYP enzymes that were tested include CYP1A2, CYP2C9, CYP2D6 and CYP3A4. Positive findings were further pursued using recombinant CYP enzymes.Techniques used: LC-MS/MS analysis, HPLC analysis, Fluorometer analysis, CYP Enzyme assays (protein based), Protein quantification, Solid phase extraction, Liquid-liquid phase extraction

• Dealt with enquiries from customers and health care professionals regarding medications and consumer products related information; feedback was warm and positive.• Dispensed prescription medicine, and counseled patients about dosage, frequency, possible side effects, and drug interactions.• Prepared extemporaneous products such as suspension, troche, capsule, ointment and cream.• Liaised with other health care professionals regarding medicine related issues.• Provided phone based customer service.

Dispensed prescription and pharmacist-only medicine, and counseled patients about dosage, side effects and drug interactions.Counseled patients about over-the-counter products and supplements.Prepared blister packs for individual patients and rest homes.Provided methadone maintenance treatment.Prepared extemporaneous products, e.g. suspension, ointment, cream, troche, shampoo, paste etc.

Project title :The influence of bile acid on methotrexate (a folic acid antagonist used to treat psoriasis and cancer) permeability in Caco-2 cell monolayers.Supervisors: Prof. Ian Tucker, Dr.Momir Mikov, Dr. Paul FawcettTechniques used: cell culture, transport studies, transepithelial electrical resistance measurement, HPLC analysis and assay validation