Reshu Tyagi Email & Phone Number

Herston, Qld, Au

Melbourne, Victoria, Australia

• Managed Case assessment, investigation, documentation, medical research, and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs).• Reviewed and assessed cases based on expectedness and seriousness and complemented with international regulations promptly.• Corresponded with the clinical trial coordinator for follow-up queries to ensure completion of patient case details.• Executed data entry and quality review of cases from Literature text, Sponsored and… Show more • Managed Case assessment, investigation, documentation, medical research, and processing of incoming Adverse Drug Events (ADEs) or Reactions (ADRs).• Reviewed and assessed cases based on expectedness and seriousness and complemented with international regulations promptly.• Corresponded with the clinical trial coordinator for follow-up queries to ensure completion of patient case details.• Executed data entry and quality review of cases from Literature text, Sponsored and Unsponsored Clinical trials, and Spontaneous and Argus ICSRs into Oracle AWARE Safety Database with emphasis on timeliness, and data accuracy, consistency, and completeness.• Completed data entry, including a collection of domestic ADR information, medical narratives, and medical reviewers’ comments and instructions with a compliance rate of 100%.• Kept current with drug regulations, revised SOPs and working instructions, and labelling updates.• Expertly handled applications like Aware MedDRAra(v 18.0) and WHO browsers.• Imparted training to Pharmacovigilance personnel on regulations, guidelines, ADR case data entry & quality review. etc. Show less

Gold Coast, Queensland, Australia

Covax Australia is a Queensland based health care company. Involved in the initial set up of Covid-19 vaccine logistics, vaccine rollout strategies, vaccine administration and Covid 19 testing.We're working with several Australian companies, agencies, Federal and State Governments to find efficient strategies to get back to normality.• Dose calculations (Adult & Paediatrics)• Assisting the lead pharmacist in preparing vaccines.• Vaccine rollout… Show more Covax Australia is a Queensland based health care company. Involved in the initial set up of Covid-19 vaccine logistics, vaccine rollout strategies, vaccine administration and Covid 19 testing.We're working with several Australian companies, agencies, Federal and State Governments to find efficient strategies to get back to normality.• Dose calculations (Adult & Paediatrics)• Assisting the lead pharmacist in preparing vaccines.• Vaccine rollout auditing.• Systematic drug storage• Batch and expiry verification• Aseptic area management• Public vaccine counselling Show less

Sydney, New South Wales, Australia

• Business/Customer Support (Pre and Post Launch support).• Brand marketing activities with the global medical and regulatory affairs teams.• Advised the PRA team with clinical and scientific information.• Supported the training of sales and medical representatives.• Supported the diabetes team in the compilation, preparation, review, and submission of regulatory dossiers.• Applied Control changes to existing products to ensure product quality.•… Show more • Business/Customer Support (Pre and Post Launch support).• Brand marketing activities with the global medical and regulatory affairs teams.• Advised the PRA team with clinical and scientific information.• Supported the training of sales and medical representatives.• Supported the diabetes team in the compilation, preparation, review, and submission of regulatory dossiers.• Applied Control changes to existing products to ensure product quality.• Reviewed regulatory authorities' website and intelligence database to communicate the applicable changes to verify compliance with product regulations.• Participated in risk management planning along with global development teams and other stakeholders.• Designed label carton for Humalog/Humulin to support regulatory submission to TGA• Edited CMI and PI for Humalog-Humulin for regulatory approval from TGA.• Edited label of a medical device Trulicity pens. Show less

Queensland, Australia

Brisbane, Queensland, Australia

• Collected, verified, recorded, and maintained data on clinical activity and/or research; prepared associated reports as required.• Ordered and maintained inventories of supplies, as required to support day-to-day unit clinical and administrative operations.• Provides day-to-day staff support for the unit, including preparing documents and reports, providing office services, scheduling and facilitating meetings and travel arrangements, and/or providing dictation or… Show more • Collected, verified, recorded, and maintained data on clinical activity and/or research; prepared associated reports as required.• Ordered and maintained inventories of supplies, as required to support day-to-day unit clinical and administrative operations.• Provides day-to-day staff support for the unit, including preparing documents and reports, providing office services, scheduling and facilitating meetings and travel arrangements, and/or providing dictation or transcription services.• Obtained and verified patient billing information, as appropriate to the activities of the unit; processes patient accounts, and maintains records.• Assisted in maintaining the cleanliness and serviceability of unit facilities and equipment; arranges maintenance and repair as needed.• Improved delivery of patient care through reviewing and implementing improvements to clinical approaches.• Confirmed accurate completion of forms and reports for admission, transfer and/or discharge of each resident.. Performed Venipuncture for the clinical trial patients. Show less

Herston, Queensland, Australia

• Monitor subject follow-up from a clinical trial.• Coordinate laboratory samples and compile data.• Collaborate with medical professionals to determine changes in subjects’ conditions• Maintained SOPs and Good Clinical Practice in compliance with ICH guidelines.• Scheduled and led team study meetings; reported findings to Lead CRA.• Screened and recruited subjects based on eligibility criteria for project participation.• Served as a point of contact for Clinical… Show more • Monitor subject follow-up from a clinical trial.• Coordinate laboratory samples and compile data.• Collaborate with medical professionals to determine changes in subjects’ conditions• Maintained SOPs and Good Clinical Practice in compliance with ICH guidelines.• Scheduled and led team study meetings; reported findings to Lead CRA.• Screened and recruited subjects based on eligibility criteria for project participation.• Served as a point of contact for Clinical Research Professionals.• Conducted pre-site visits and performed site evaluations.• Followed informed consent processes and maintained records.• Gathered, Processed ad shipped lab specimens.• Conducted all activities according to defined project-specific quality and performance standards as well as relevant standard operation procedures (SOPs), good clinical practices (GCPs) and local requirements.• Liaised with vendors for protocol adherence and checked clinical supplies at investigational sites. Show less

New Delhi, Delhi, India

• Educated patients regarding all facets of clinical study participation.• Managed updates and input for patient information database.• Assisted with research protocol development.• Collected data and followed research protocols, operations manuals and case report form requirements.• Screened patient records, databases and physician referrals to identify prospective candidates for research studies.• Worked with principal investigator and sponsors to facilitate daily… Show more • Educated patients regarding all facets of clinical study participation.• Managed updates and input for patient information database.• Assisted with research protocol development.• Collected data and followed research protocols, operations manuals and case report form requirements.• Screened patient records, databases and physician referrals to identify prospective candidates for research studies.• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.• Followed informed consent processes and maintained records.• Performed administration tasks, such as word processing, data entry, answering phones and filing.• Taught patients about medications, procedures and care plan instructions.• Managed investigator site files and essential documents as per standards of GCP. Show less

India

• Inspected and Labelled Raw materials against the specifications and SOPS.• Maintained the controlled documents and edited SOPs.• Performed in-process inspection.• Performed inspection on finished products before they are packed.• Packaging of the finished products.• Assisted in writing and updating inspection checklist and reports.• Assured accuracy and Correctness of data and maintained inspection result in history records.• Maintained safe and healthy environment… Show more • Inspected and Labelled Raw materials against the specifications and SOPS.• Maintained the controlled documents and edited SOPs.• Performed in-process inspection.• Performed inspection on finished products before they are packed.• Packaging of the finished products.• Assisted in writing and updating inspection checklist and reports.• Assured accuracy and Correctness of data and maintained inspection result in history records.• Maintained safe and healthy environment by following standards and procedures. Show less

Gurugram, Haryana, India

• Validation of medical claims.• Review of policy documentations.• Claim settlement negotiations.• Advising clients regarding legal non-negotiable settlements.• Systematic medical claim documentation.• Determine benefit due, and payment processing.

Masters Of Pharmaceutical Industry Practice, Pharmacy, 6

Relevant Coursework: Pre-Clinical Drug Development, Pharmacoeconomics, Project Management and Commercialization, Clinical Drug Development.

Education record