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Rimita Chanda

Experienced and certified drug safety specialist

Lake Hiawatha, NJ

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▫ Currently working in Quintiles as a Drug Safety Specialist from December 2011 till date 
 
▫ Worked in ICON Clinical Research, (Pharmacovigilance) as Drug Safety Associate for 6 months 
 
▫ Worked in Clinical Research-Operations department of Tripod Computing Services, as Manager-Clinical Research for a period of 6 months 
 
▫ Worked as Clinical Data Analyst in Tripod Computing Services for a period of 1.5 year 
 
▫ Worked as Coordinator-Clinical Research in IPCA Laboratories for a period of 1.5 year 
 
▫ Post Graduate Certificate in Clinical Research and Clinical Data Management from University of Pune. (June 2008) 
 
▫ National Institute of health (NIH), Collaborative Institutional Training Initiative (CITI) certified.(International Certifications on Clinical Research) 
 
▫ Certified by NTI on Corrective and Preventive Actions Procedures. (Score-90%) (International certifications on Clinical research) 
 
▫ Master of Science in MICROBIOLOGY in year 2006 from University of Pune

Work Experience

Drug Safety Specialist

Quintiles, INC
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Parsippany, NJ
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December 2011 to Present

 Handling safety issues of two phase 3 trials (cardiovascular study) simultaneously by managing all the SAEs from initial reporting till case closure 
 Follow-up each case and handle them individually depending upon their importance 
 Worked in Book-in, triaging, data entry+processing and QC with case closure team as well 
 Given special responsibilities to handle highly important cases which are SUSARS and FATAL/LIFE THREATENING and needs expedited reporting within few hours. 
 Worked in overdose cases and handled these specialty cases carefully along with creating and distributing overdose notifications for all the Principle Investigators around the world ASAP 
 Ensuring triage of incoming cases by determining seriousness and prioritizing case processing according to timeframes stated in SOP as per regulatory and company requirements 
 Handling and reviewing relevant safety tracking system (ArisG) for accuracy and quality 
 Coding adverse events and medications with help of latest coding standards in MedDRA 
 Writing of narratives (CIOMS/3500A) on each safety report processed 
 Processing each and every case individually, by assessing the safety issues and prioritizing them accordingly before submitting them to the FDA 
 Documenting and processing SAEs study specific procedures within company, regulatory authorities of USA and sponsor regulation and timeframes 
 Creating Urgent Safety queries and safety queries in INFORM and communicating with the sites all over the world over phone and through e-mail in order to process safety issues as required. 
 Provide support for Global Drug Safety reports eg. PSUR, administrative reports for management etc. 
 Performing safety related training for new employees on requirement

Drug Safety Associate

ICON Clinical Research
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Chennai, Tamil Nadu
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June 2010 to December 2011

 Handling pharmacovigilance issues of an US Pharmaceutical Company 
 Monitoring and tracking SAE, serious and non-serious ADRs and other medically related project information 
 Handling and reviewing relevant safety tracking system (ARGUS) for accuracy and quality and maintain paper files. 
 Documenting and processing SAEs, spontaneously reported AEs and other safety and medically related information per study specific procedures within company, regulatory authorities of USA and sponsor regulation and timeframes 
 Completing full case information on the database ensuring quality by accuracy and completeness of each case 
 Ensuring triage of incoming cases by determining seriousness and prioritizing case processing according to timeframes stated in SOP as per regulatory and company requirements 
 Processing literature cases and identifying relevant information from publications before processing them as separate cases along with their safety concern contents 
 Coding adverse events and medications with help of latest coding standards in MedDRA 
 Entering data into safety database and seeking clarifications for illegible or insensible data 
 Discussing with physician regarding each case with events, seriousness, outcome, action taken and medications 
 Writing of narratives (CIOMS/3500A) on each safety report processed 
 Processing each and every case individually, by assessing the safety issues and prioritizing them accordingly before submitting them to the FDA 
 Performing safety review of clinical data (CRFs) and patient laboratory documentations 
 Assisting medical monitor in documentation and processing source documents and proper medical information retrieval. 
 Liaising with investigational sites and reporters on safety related issues 
 Serving as medical resource to investigational sites and Company personnel on safety related issues 
 Performing safety related training for extra-department company staff

Supervisor-Clinical research

Tripod Computing Services Pvt. Ltd
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Kolkata, West Bengal
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January 2010 to May 2010

• Supervising and managing a team in clinical safety department 
• Working for US Client and a Global CRO on US regulatory authorities FDA 
• Validating ARGUS processed cases after data entry into the safety database 
• Writing narratives and quality checking for each case in validation process 
• Validating each processed case entered into Argus before routing them for local case assessment onsite 
• Managing a team of clinical research operations. 
• Prepared website materials, Tri-folds, SOPs and other forms and documents required for initial project assignments 
• Involved in Investigator Selection procedure 
• Project explanation and Clinical research training presentations  
• Responsible for Site Selection Process, Site Feasibility Study. 
• Maintained the Study Documents 
• Ensure that Site should conduct study according to Protocol, compliant with ICH-GCP guidelines and regulatory norms. 
• Preparation of Study Specific and General SOPs and study Logs  
• GCP and SOP training of all investigators and site staffs. 
• Have successfully constructed an end to end process flow of Clinical Research along with Clinical Data Management with details regulatory compliance of countries like US and India single-handedly 
• Training material preparation for in-house training to team on Clinical research and clinical data management processes 
• I was also involved in many top management decisions as I was the key person in setting up the process running for the company from scratch

Clinical Data Analyst

Tripod Computing Services
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Kolkata, West Bengal
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August 2008 to December 2009

• Handling pharmacovigilance issues of an US Pharmaceutical Company 
• Analysis of safety data in eCRFs and processing them in ARGUS 
• Monitoring and tracking SAE, serious and non-serious ADRs and other medically related project information.  
• To document and process SAEs, spontaneously reported AEs and other safety and medically related information per study specific procedures within company, regulatory authorities of USA and sponsor regulation and timeframes. 
• Prioritizing safety data and submission of them accordingly in FDA 
• Query resolution and QC of all data discrepancies before data transport. 
• Coding adverse events on medDRA 
• Coding Laboratory tests, medical history and current medical conditions on ARGUS 
• Process each initial AE and their Follow-up according to the information available and submit them to FDA on time

Clinical Research Coordinator

IPCA Traditional Remedies
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Mumbai, Maharashtra
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January 2007 to June 2008

Worked in a Single arm, open label controlled clinical study in the treatment of refractory/chronic migraine patients 
• Participated in an in-house trial of Migraine and was assisting the trial as an Clinical Research coordinator directly under the Principal Investigator 
• Assisted total Informed Consent process 
• Attended all subjects from first to last visit at site 
• Perform Electronic Data Entry for all trial related data from Source documents to eCRFs 
• Responsible for completion of all study documentation forms, including case report forms and other study specific documents 
• Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the clinical protocol 
• Interact with Principal Investigator as needed to assure patient receives appropriate medical evaluation and care when needed 
• Alerts Principal Investigator of serious adverse events 
• Attends sponsor Investigator/Study Coordinator meetings as needed for assigned protocols 
• Conducts clinical research in compliance with all applicable regulations 
• Interacts with sponsor Clinical Research Associate to facilitate the sponsor monitoring 
• Conducts clinical research in compliance with all applicable regulations

Education

Professional Certificate in Clinical Research & Clinical Data Management

National Institute of health

January 2009 to January 2009

Post Graduate Certification. in Clinical Research and Clinical Data Management

University of Pune -
Pune, Maharashtra

January 2008 to January 2008

Masters in Microbiology

University of Pune -
Pune, Maharashtra

January 2004 to January 2006

Bachelors in Microbiology

University of Pune -
Pune, Maharashtra

January 2001 to January 2004

H.S.C. in Science

West Bengal Board of Higher Secondary Education -
Kolkata, West Bengal

January 1999 to January 2001

S.S.C. in General

West Bengal Board of Secondary Education -
Kolkata, West Bengal

January 1997 to January 1999

Skills

ARGUS, Arisg, INFORM proficient

Additional Information

Computer Skills: 
Operating System: Familiar with operating systems, their working and Microsoft Office. 
 
❑ Selected as academic award winner in first & second year of Bachelors degree