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<pre>Array ( [var] => cut_url ) </pre> Resume for Vivek C. for Dentist / Dental Surgeon / Biotechnology & Pharmaceuticals in Chennai, India. Search More Resumes for Dentist / Dental Surgeon on Resumark.com #1KTVSU4FV
 

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Resume for Vivek C. for Dentist / Dental Surgeon / Biotechnology & Pharmaceuticals in Chennai, India




Occupation: Dentist / Dental Surgeon Industry: Biotechnology & Pharmaceuticals
Country: India City: Chennai
State: Tamil Nadu ZIP: 600004



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      BIODATA 
 
 

Dr. VIVEK .C

B, Shanti apartments,

No: /, Balakrishna road,

Mylapore.                      Cell: +                                                                                                                                   Chennai – .         

Tamil nadu.        Email:

India.                                                                                         

                                 

OBJECTIVES 

      To pursue a challenging career in clinical research especially in Pharmacovigilance Drug Safety and in clinical monitoring where I can put all my knowledge acquire skills and contribute to the growth of my career, my team and effectively to the organization. 
 

PERSONAL ATTRIBUTES:

  • Highly motivated, dynamic, disciplined, confident, and goal oriented.
  • A selfdirected professional with excellent clinical, communication, interpersonal and problem solving skills
  • Combine resourcefulness and problem solving skills with clinical knowledge to consistently deliver improved research and production results.
  • Good Team player dedicated to quality, continuous improvement and bottomline objectives.
  • Good knowledge in ICH GCP and Medical Terminologies.
  • Able to work independently in safety related duties manage and mentor other employees.
  • Good Leadership and team building skills.
  •  OVERALL EXPERIENCE – yrs and months 

  • Consultant – Pharmacovigilance in HCL Technologies Ltd – From Aug to till date.
  • Private Dental Practitioner from Nov to till date.
  • Senior Drug Safety Associate in MMSH clinical research Pvt.Ltd – From Jan to Jul .
  • Drug Safety Associate in Icon clinical research – From Jan to Dec
  •  WORK EXPERIENCE 

  • Currently working as Pharmacovigilance Consultant in HCL Technologies Ltd, Chennai, India.
  • Worked as Senior Drug Safety associate in MMSH clinical research, Bangalore, Karnataka, India.
  • Worked as a Drug Safety Associate in Pharmacovigilance at ICON Clinical Research, Chennai, Tamilnadu, India.
  • Worked as a Lead DSA for the projects involved and directly reporting to project manager and mentoring the reporting DSA’s.
  • More than three years of clinical experience and Pharmacovigilance experience.
  • Assisted in setting up a Pharmacovigilance department and PV call center Adverse event reporting center in MMSH clinical research Pvt, Ltd. India.
  •  
     

    COMPANY DETAILS:

     
    HCL Technologies LTD:
     

    HCL Technologies is a global IT services company headquartered in Noida, a suburb of Delhi India. It is a billion$ enterprise. The life science vertical of HCL service offerings in pharmaceutical area includes Clinical trail management, Clinical data management, Pharmacovigilance, Medical writing and Analytical services. 

    MMSH Clinical research: 

    The company is an ISO : Certified organization located in Canton, Michigan. They provide clinical development support, medical writing, clinical programming, biostatistics, Pharmacovigilance services and regulatory affairs services to the pharmaceutical, biotechnology and medical device industry. 

    Icon clinical research: 

    The Company is the global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Specialized in the strategic development, management and analysis of programs that support Clinical Development, i.e., from compound selection to Phase IIV clinical studies In that medical and safety services includes Medical affairs, Drug safety, Medical writing, Phase IV studies and registries many other full service programs. 
     
     
     
     
     

    Pharmacovigilance & Clinical Research Skill: 

  • SAE processing, narrative writing and Reporting Paper format and Safety databases
  • Medical/Safety Review and Safety Data analysis in live clinical trials.
  • Post marketing Safety Review and Safety Data Analysis. Using safety database
  • Case Report form Safety Review and query generation. Clinical Database
  • Laboratory Safety Review & data analysis, data interpretation in graphs and tables.
  • Literature review & Feasibility surveys.
  • Safety Narrative writing.
  • PSUR writing.
  • MedDRA Coding., WHO coding.
  • Project Metrics and FTE preparation.
  • Preparing SOPs and workflows.
  • Study Master File maintenance & Project audit preparation.
  • Coordinating Pharmacovigilance Training and mentoring DSA’s
  •  

    Primary Duties:  

    Assisting in setting up of Pharmacovigilance practice and dept in HCL technologies Ltd. 

    Conducting internal Pharmacovigilance trainings and workshops. 

    Attending Business calls with clients in order to get project and responding to RFP’s. 

    Supervision of other Drug Safety Associates and Administrative staff in conjunction with the Medical Monitor. 

      Ensure all project safety activities are completed in accordance with SOPs, SSPs, and other applicable regulations. 

      Maintain and review department status reports, keep upper management apprised of any potential/actual study or staffing issues, and assist with developing solutions.  

      Supervise project audit preparation and project audit process Maintain metric/staffing reports with thin the team. 

      Interdepartmental liaison between medical staff and other departments for project related issues. 

      Ensure participation at all Quality Review meetings pertaining to medical projects with in the team.  

      Supervise File Room activities and maintenance of File Room Maintain study activity checklists to define scope of work for each project with the help of medical monitor.  

      Liaison between medical staff MM, DSA, and Management for project related issues as required. 

      Preparation of presentations and other relevant records for training the candidates in Pharmacovigilance department. 

      Preparation of work flow, templates and forms needed for the PV department. 

      Assist with department training and identify training needs as necessary. 

      Mentoring Drug safety associate – ELs and DSAs in Pharmacovigilance duties. 

      Preparation of metrics for the projects and the team. 
     

    Others:  
    . Receive, track, and assess AE and SAE reports from all sources including postmarketing, clinical trial, and literature sources. 
    Document and process serious adverse event reports within company, regulatory authorities and sponsor regulations and timeframes and enter data into adverse event database / tracking system and paper files.
     

    . ARISg, Argus, Oracle AERS, OC RDC, Oracle clinical and ARIS exchange IRT working experience.

     
    . Perform administrative tasks relevant to the role to include maintenance of tracking systems, paper files and any other administrative tasks as required.

     
    . Liaise with investigational sites and sponsors on safety related issues.

     
    . Assist medical monitor in review and followup of laboratory abnormalities and perform safety review of clinical data. Create graphs and tables for the reported lab data. 

     
    . Perform tasks resulting from departmental interfaces, e. g. with data management listing review, SAE reconciliation, medical writing narrative review and writing.

     
    . Review study documents and setup study specific processes together with the assigned medical monitor and generate the corresponding procedures.
     

    . Worked in literature review projects and feasibility studies.  

           Reviewing literature article, identifying adverse drug reactions ADRs raising CIOMS forms and narrative when required.

          

    . Experienced in CRF safety review related works and finding hidden SAE/AE and other queries to site as well as to data management. 

    . Good working OPTICON medical review Oracle clinical and RAVE medidata. 

    . ICH GCP trained and trained in MEDRA Coding. 

    . Good knowledge in preparing metrics and FTE calculations in MS excel. 

    . Preparing and maintaining Study Master File and preparing CDDF and maintaining all study related documents.  

    Project Details: 

    SAE Processing and Reporting:  

    . This project was done for one of the big pharmaceutical company from Japan, providing medical monitoring support globally for the product used for Type Diabetes in their clinical trial. The main duties from the Pharmacovigilance/drug safety team is to find out the adverse events from the case report forms, raise missing queries, coordinating with hospitals/clinical trial sites in order to get the relevant information for processing the case and send the package to the sponsor. 

    Therapeutic area: Type diabetes Mellitus

    Responsibilities:

  • SAE processing and reporting.
  • Deficiency list preparation.
  • Narrative writing.
  • Contacting the trial site for relevant information.
  • Case report form safety review using OptICON and find AEs.
  • Laboratory Data analysis.
  • Assisting medical monitor in medical safety review.
  •  

    Role: Drug Safety Associate 

    . This Project was done for the top pharmaceutical company from France with their major therapeutic areas like Cardiovascular, Oncology & Thrombosis providing clinical trail, medical monitoring and Drug safety support in clinical Trails. The main duties from the Pharmacovigilance team is to Check any Serious adverse events has been reported, prepare deficiency list from the information received and raise query to the investigator for missing information and as well as to data management by using Oracle clinical Remote Data CaptureOCRDC to process the case. 

    Therapeutic areas: Thrombosis, Cardiovascular, Oncology

    Responsibilities:

    . SAE processing and reporting.

    . Deficiency list preparation.

    . Contacting the trial site for relevant or missing information.

    . Use OCRDC to check the adverse and other data.

    . Raise queries to Investigator and Data management for missing information.

    . Lab Safety data analysis.

    . Study Master file maintenance.  

    Role: Drug Safety Associate 
     

    Post marketing support:  

    . The post marketing support was mainly given to the products of the pharmaceutical company located in Geneva as their headquarters. The main responsibilities of the Pharmacovigilance team were to do post marketing literature searches and enter the case into CFR Validated Safety database ARISg and process the case. Also pro


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