Mini JOSHI

En résumé

Entreprises

• Cognizant Technology Solutions - Quality Reviewer & Medical Safety Specialist

  Paris 2014 - 2017 Quality Reviewer, Medical Safety Specialist in Pharmacovigilance
  
  * Assessment of initial ICSRs for their validity criteria and case processing in ARISg ;
  * End to end Case processing of serious & non serious ICSRs both solicited and spontaneous.
  
  * Coding Experience in MedDRA and WHO DD. Coding and assessing the Adverse Events using MedDRA dictionary and drugs using WHO DD
  
  * Quality Review of non serious ICSRs both solicited and spontaneous and ensuring 100% accuracy.
  
  * Constant communication with client and vendors for handling ICSR related queries and ensuring the same is communicated to the team.
  
  Website: https://www.cognizant.com/life-sciences/pharmacovigilance

• Cognizant Technology Solutions - Quality Reviewer/ Medical Safety specialist

  Paris 2014 - 2017 • Assessment of initial ICSRs for their validity criteria and case processing in ARISg
  • End to end Case processing of serious & non serious ICSRs both solicited and spontaneous.
  
  • Coding Experience in MedDRA and WHO DD. Coding and assessing the Adverse Events using MedDRA dictionary and drugs using WHO DD
  
  • Quality Review of non serious ICSRs both solicited and spontaneous and ensuring 100% accuracy.
  
  • Constant communication with client and vendors for handling ICSR related queries and ensuring the same is communicated to the team.
  
  Website: https://www.cognizant.com/life-sciences/pharmacovigilance
  

• Tata Consultancy Services - Pharmacovigilance Scientist level I

  Puteaux 2012 - 2014 • Assessment of initial ICSRs for their validity criteria and case processing in ARISg
  • Coding Experience in MedDRA and WHO DD. Coding and assessing the Adverse Events using MedDRA dictionary and drugs using WHO DD
  
  • End to end Case processing of all types of ICSRs (serious, non-serious, spontaneous, clinical, solicited, interventional programs and literature case processing)
  
  • Identifying SUSAR and triaging them to avoid Regulatory Noncompliance.
  • Assessing the labeling documents and good narrative writing practice that makes medical sense
  • Distribution of cases within team as back up and sending alerts about regulatory due cases and potential SUSAR
  

• TATA Consultancy Services - Drug safety associate/Pharmacovigilance scientist level I

  Puteaux 2012 - 2014 Website: https://www.cognizant.com/life-sciences/pharmacovigilance
  
  * Assessment of initial ICSRs for their validity criteria and case processing in ARISg
  * Coding Experience in MedDRA and WHO DD. Coding and assessing the Adverse Events using MedDRA dictionary and drugs using WHO DD
  
  * End to end Case processing of all types of ICSRs (serious, non-serious, spontaneous, clinical, solicited, interventional programs and literature case processing)
  
  * Identifying SUSAR and triaging them to avoid Regulatory Noncompliance.
  * Assessing the labeling documents and good narrative writing practice that makes medical sense
  * Distribution of cases within team as back up and sending alerts about regulatory due cases and potential SUSAR
  Professional Achievements
  
  * Received many client appreciations for identifying the data correction and processing the SUSAR proactively in timely manner
  * Skilled at running the reports in ARISg and workflow distribution
  * Signed off for literature case processing within four week
  * Efficient in identifying the valid and invalid literature articles
  * Assessment of the correct events terms from the article and identifying the signal detection.
  
  Major projects carried out at TCS:
  
  * Completed SPS (Structured Problem Solving) project on `` Incorrect assessment of ICSRs and wrong disposal to ARISg''
  * Successful implementation and achieved 30% of improvement by reducing the error rate from 6.32% to 4.12%. ;
  * Key member in creating and publishing the process monthly bulletin which included all the updates, progress and achievements of process.
  * Carried out root cause analysis for the errors occurring in labeling part for than 500 cases of therapeutic alignment and suggested corrective and preventive measures for the same.
  * Conducted presentation about pregnancy cases and conventions to follow in the same.
  
  Website: https://www.tcs.com/business-operations/life-sciences-business-operations

• Cadila Healthcare - Quality Analyst in finished products

  Gujarat 2009 - 2010 • Performed the analysis of different physical, chemical properties, Quantitative and Qualitative parameters of various drug samples followed by Estimation of active ingredients and assay by HPLC, GC, U.V spectrometer, F.T.I.R, Dissolution apparatus. sample preparation ,calibration of PH meter and other analytical instruments
  • Reviewing SOPs and revising them regularly.
  

• Cadila Pharmaceutical Ltd. - QC Product Analyst

  2009 - 2010 * Performed the analysis of different physical, chemical properties, Quantitative and Qualitative parameters of various drug samples followed by Estimation of active ingredients and assay by HPLC, GC, U.V spectrometer, F.T.I.R, Dissolution apparatus. sample preparation ,calibration of PH meter and other analytical instruments
  * Reviewing SOPs and revising them regularly.
  
  Website: http://cadilapharma.com/

Formations

• Cambridge Institute Of Language (Mumbai)

  Mumbai 2017 - maintenant Diplôme d'études en langue française
  
  (Pursuing the next level)

• Cambridge University Of Languages (Mumbai)

  Mumbai 2017 - 2017 A1
  
  Further pursuing for level A2 in France

• Rajiv Gandhi University Of Health Sciences (Bangalore)

  Bangalore 2010 - 2011 M.pharm (pharmacology)

• Rajiv Gandhi University Of Health Sciences (Bangalore)

  Bangalore 2010 - 2012 Masters in Pharmacy with pharmacology specialisation
  
  Masters in Pharmacy with pharmacology specialisation

• Rajiv Gandhi University Of Health Sciences (Bangalore)

  Bangalore 2005 - 2009 Bachelors Degree in pharmacy

• Rajiv Gandhi University Of Health Sciences (Bangalore)

  Bangalore 2005 - 2009 B.pharm

Réseau

Pas de contact professionnel