Experience

East Metropolitan Health Service

• Australia
• Hospitals and Health Care
• 300 - 400 Employee

• Medical Secretary- Outpatients

  • Apr 2022 - Present

  Experienced in transcription of clinic letters of paediatrics, general medicine, general surgery, infectious medicine, diabetics, obstetrics and gynaecology, urology, renal medicine, rheumatology, orthopaedics, trauma, palliative care, gastroenterology and endocrinology. Experienced in providing data entry administrative support to integrated hospital packages (IHP) and responsibilities include creating IHP referrals in IHP site and Webpas, adding discharge of patients in IHP and Webpas, entry of invoices in IHP and service events in Webpas, archival of IHP documents in patients’ medical records. Show less

• Medical Secretary Paediatrics

  • Mar 2021 - Present

• Administrative Clerk

  • Oct 2020 - Feb 2021



Linear Clinical Research Ltd

• Australia
• Research Services
• 100 - 200 Employee

• Clinical Trial Administrator

  • Aug 2018 - May 2019

  1) Ensuring that activities for clinical trial projects are conducted in accordance with the relevant protocol, regulations, GCP guidelines, company SOPs and standards of best practice. 2) Effective management of trial documentation. 3) Project management: a) understanding of protocols, GCP guidelines, company SOPs and standards b) accurate preparation, maintanence and archival of trial documentation and records (both electronic and paper) c) maintanence of site file binders by filing essential documents d) quality control checks of source documents and resolution of queries e) identification, escalation and addressal of breaches of protocol, ICH/GCP guidelines, regulatory requirements and SOPs to clinical trial project manager and coordinator f) ordering of clinical trial materials, maintence of stock and discarding expired products g) accurate data entry into electronic case report form h) supporting clinical team with onstudy activites (which include screening of participants for study based on inclusion-exclusion criteria, taking care of onstudy clinical trial participant’s follow up visits and conducting assessments, clinical trial sample collections, oral drug administration, recording study participant’s investigational product compliance and drug dispensing) i) assist in monitoring, close outs and archivals. 4) Client management: a) maintenance of effective relationship with participants, monitors, vendors, sponsors and other teams as required b) communicating with participants, monitors and vendors in a professional manner c) recording and monitoring participant attendance accurately. 5) Audit support 6) Active participation in training and development opportunities 7) Identifying areas of improvement within systems and areas for reducing operating costs and communicating it to the manager 8) Training and mentoring of new associates. 9) Coordinator for C-SSRS assessment. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior safety processing expert

  • Apr 2014 - Mar 2017

  1. Receive AEs, perform duplicate search before book in and create case file in Argus.2. Coding of medical history, current conditions, laboratory tests, procedures and AEs by MedDRA3. Coding of historic, suspect, concomitant and treatment medications by WHO dictionary. 4. Writing medical narrative and summarising events for spontaneous reports, literatures, PMS reports according to GVP guidelines, departmental, standard operating procedures (SOPs), product guidance documents (PGDs) and through assessment of all source documents. 5.Complete processing and locking of non-serious case after proper quality check and routing serious cases to the next level for locking6. Identifying and initiating follow up for missing relevant clinical information.7. Deactivation of non-valid cases in Argus.8. Working closely with other Novartis global sites 9.Supporting project activities of Drug safety and epidemiology as required.10. Point of contact of NVD team for offline QC tool corrections. 11. Mentoring of new associates and internships.12. Updating NVx PGDs and sections of Manual of Argus Processing(MAP).13.Handling QA automation (requesting QA department for standard QA investigations for product technical complaints and mixed complaints), PTC queries and PTC tracker14. Handling of IMAN/SPA (product investigation summary assignments) . 15. Global Drug Safety Responsible and Source Data Verifier (SDV) co-ordinator for patient oriented programs (POP):Responsibilities as DSR includes: ensure accurate and timely entry of drug safety related activities into the POP sys. Activities include review of classification questionnaire and approval of POP classification, reduce likelihood of AE reporting, Novartis contact for drug safety related activities like AE training, queries regarding AE and special case scenarios, monitoring activities like AE reconciliation. Responsibilities as SDV co-ordinator include review of SDV results sent by vendor.16. PV audit support. Show less

• Safety Processing Expert

  • Apr 2011 - Mar 2014

  1. Receive adverse events, perform adequate duplicate search in data base before book in and create case file in Argus2. Coding of medical history, current conditions, laboratory tests, procedures and adverse events by MedDRA3. Coding of historic, suspect, concomitant and treatment medications by WHO dictionary4. Writing medical narrative as per GVP guidelines, SOPs, PGDs and other departmental documents.5.Complete processing and locking of non-serious case after proper quality check and routing serious cases to the next level for locking6. Identifying and initiating follow up for missing relevant clinical information.7. Deactivation of non-valid cases in Argus database8. Working closely with other Novartis global sites 9.Supporting project activities of Drug safety and epidemiology as required.10. Point of contact of NVD team for offline QC tool corrections. 11. Mentoring of new associates.12. Audit support. Show less

• Safety Associate

  • Mar 2009 - Mar 2011

  1. Initial receipt, triage and acknowledgment of individual case safety reports (ICSR) from country organisations (CO) in drug safety tracking tool, Safety Information Notification Application (SINA) database and mail boxes. 2. Receiving and forwarding queries to responsible personnel or replying it3. Deletion of deactivated cases from Argus data base4. Accurate indexing of case files and archival of source documents5. Training of new associates 6. Providing assistance to audit as per requirement7. Management of drug safety mailboxes8. Submission of literature articles to regulatory authorities9. End of study unblinding10.Coordinator for safety associates team and responsibilities included preparation of duty roster, managing work in case of unplanned absences, liaising with the team and providing daily work update to the team leader. Show less



Manipal Acunova

• India
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Study coordinator trainee

  • May 2008 - Oct 2008

  1. Assisting in site initiation, site selection and site close out visits 2. Assisting investigators in informed consent process 3. Screening of potential patients as per study inclusion-exclusion criteria 4. Randomization of patients by IVRS 5. Dispensing of medication to patients 6. Coordinating patients‘ trial visits, laboratory tests and other procedures. 7. Archival of study documents appropriately as per sponsor requirements. 8. Data entry of eCRF, completion of temperature, freezer, equipment and subject enrolment, pre-screening, screening, drug dispensing logs 9.Preparation of drafts for ethics committee 10. Shipment of ambient and frozen clinical samples 11. Drug accountability 12 Protocol reviewal Show less



St Johns Medical College

• Bangalore, India

• Jr Lab technician

  • Jul 2006 - Jul 2007

  Performed Bacteriology, Serology, Mycology, Virology and Mycobacteriology testing on various clinical specimens in a routine laboratory environment. Responsibilities included: 1) Preparation of culture media and broth for pathogen testing. 2) Loaded and processed blood cultures in BACTAC automated machine. 3) Prepares and interprets a variety of stains including Gram stain, KOH, Indian ink stain and Ziehl Neelsen stain. 4) Microscopic examination of microorganisms to determine their morphological and physiological characteristics. 5) Isolation of microorganisms through cultures and identification through biochemical tests. 6) Serogrouping and serotyping of bacteria, 7) Antibiotic sensitivity testing. 8) Performs standard serological tests for identifying antibodies/antigen using rapid microbiological tests. Serology testing included WIDAL, Brucella agglutination, latex agglutination, VDRL, Rapid Plasma Reagin test, immune assays, hemagglutination tests, ELISA and Western blot test. 9) Mycobacterial tests, isolation and identificationMycobacterial tests, isolation and identificationMycobacterial tests, isolation and identificationMycobacterial tests, isolation and identification. 10) Fungal/yeast staining, culture and identification. 11) Applies parasitological techniques to recover and identify parasites. 12) Water analysis. 13) Performs quality control on new reagents. Show less