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engineering Freelancer

About me:

Work Summary: 

● Adverse Event,Product Complaint,Medical Information, Case Intake, Receipt, Triage (Inbound calls/Outbound Calls ) 
● Narrative writing for adverse event and product complain cases. 
● Responsible for email, call, fax and mail followup for additional information. 
● Responsible for maintaining adverse event, product complaints, medical information, case reconciliation tracker. 
● Responsible for initiating prepaid mailer and follow-up. 
● Thorough knowledge of Good Clinical Practices (GCP) and GLP guidelines 
● Expert knowledge of ICH and global regulatory guidelines. 
● Good knowledge of global regulatory affairs procedures 
● Excellent organizational skills and exceptional attention to detail 
● Good working knowledge of scientific terminology, pharmacology, pharmacotherapeutics, medical, pharmaceutical and research concepts 
● Ability to work collaboratively, meet deadlines, have attention to details, perform multiple tasks simultaneously and prioritize 
● Working knowledge of applicable computer systems. 
● Strong communication skills 
● Proficiency in Microsoft Word and Excel programs 
● Strong experience with Microsoft Word, Excel, and PowerPoint 
● Excellent interpersonal skills 
● Proficient use of English language

Education:

Doctor Pharmacy (Pharm D) 

Experience:

Total Experience:

Bioclinica Pvt Ltd: 3 Years 

KG Hospital & Post Graduate Research Institute: 1 Year 

Technical Skills: 

Tools and Technologies: Microsoft Word and Excel, IRMS, IRT Operating System: Windows 10

Company: Bioclinica Private Limited 
Duration: Jan 2017 - Dec 2019
Role: Responsible for adverse event case intake, duplicate check, registration and triage in IRT. Review and evaluate AE case information to determine required action based on and following internal policies and procedures. Maintain log of source documents, and other communications. Process all incoming cases in order to meet timelines. Responsible for coding of all medical events, drugs /procedures/implements according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD). Responsible for writing medically relevant Safety narrative of cases and checking the completeness and accuracy of the medical data entered in the various fields. 

Industry: KG Hospital & Post Graduate Research Institute, Coimbatore, 
Duration: Jan 2016 – Dec 2016 
Responsibilities: Attending ward rounds, Checking Medication Adherence, Adverse Reactions & Drug Interactions Checking, Patient Counselling, Prescription Analysis & other clinical Pharmacy services in all major departments in hospital. 

Academic Projects: 

TITLE: The comparison of teach back method and standard method for new prescription education during counselling sessions in the department of psychiatry

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