Nethiya Rubinee Email & Phone Number

London Area, United Kingdom

Luton, England, United Kingdom

Key responsibilities•Worked closely together with CRA’s, investigators and study coordinators to ensure all study documents are collected throughout the duration of the study•Set up and maintained the local eTMF and ISF including document tracking in accordance with ICH-GCP requirements and maintained the eTMF “Inspection Readiness”•Worked closely with the global team to ensure timely delivery of equipment and materials to study sites•Created/imported clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents•Assisted Local Study Manager in submission of proper application/documents to EC/IRB and where appropriate to Regulatory Authorities •Contributed to the production and maintenance of study documents such as ICFs, Protocol Acceptance Forms etcKey achievements/projects•Provided study start-up training to newly appointed clinical study administrators, ensuring their readiness to support clinical research activities.•Contributed to the successful implementation of a process change aimed at improving the localization of informed consent forms, resulting in reduced turnaround time and efficiency in clinical trial operations.•Successfully facilitated meeting site activation targets ahead of schedule through effective administrative support and coordination for respiratory study

Selangor, Malaysia

• Developed, updated and implemented quality management systems to ensure compliance with Good Distribution Practice (GDP) and national requirements• Led investigation for root cause analysis & CAPA reporting for product quality complaints• Reviewed accuracy of information entered into product quality complaints database and ensured timely submission of CAPA reports to the National Pharmaceutical Regulatory Agency (NPRA) Malaysia or customers• Performed reconciliation of product complaints received with Unimed’s vendors• Led audit committee for unannounced audits by NPRA, Medical Device Authority (MDA) Malaysia, vendors, contract manufacturers and internal audit• Initiated and coordinated nationwide product recalls of pharmaceuticals e.g. Ranitidine• Prepared and submitted regulatory file applications and supporting documents for medicaldevice registration to MDA• Responsible for drug license maintenance and renewals including import licenses and import permits for unregistered drugsKey achievements/projects• Reduced product complaints originating from suboptimal storage conditions by 60% by revamping warehouse SOP on quality control checking of goods• Pioneered the commercialization of dangerous drugs within the organization (Fentanyl Injection)• Set up company’s first Time and Temperature Sensitive Product (TTSP) storage facility – SOP, warehouse personnel training, documents submission, and internal & NPRA audit• Launched annual training program for warehouse personnel on GDP requirements• Assisted in development of company’s first set of Pharmacovigilance SOPs

Batu Caves, Selangor, Malaysia

-Pharmacist at outpatient department-Screening prescriptions and identifying any errors in dosage of drugs-Dispensing medication within the departments of dermatology, urology, psychiatry, surgical, orthopaedics, nephrology, pain management and palliative care-Counselling patients regarding medication and usage of medical devices like insulin pen and inhalers-Addressing drug related queries from healthcare professionals and patients-Recommending drug therapy changes when needed-Therapeutic Drug Monitoring -Supervising the inventory of pharmacy stock and determining supplies needed-Reporting adverse drug reactions (ADR)-Involved in medication via post (UMP) team

Batu Caves, Selangor, Malaysia

1 year of pre-registration training in the following pharmacy departments of the hospital:a) Out-patientb) In-patientc) Clinical Pharmacokinetic Servicesd) Drug & Poison Informatione) Manufacturing & Prepacking f) Inventory/Store Managementg) Cytotoxic Drug Reconstitution Services-Attached under the hepatobiliary ward and infectious disease ward for ward pharmacyattachments

Kuala Lumpur, Malaysia

Assisted with document preparation required by health authorities to carry out new drug registration, variation application for drug products, post marketing surveillance and drug registration & licence renewal.