Pramod Dighe

FAQ About Pramod Dighe

• What is Pramod Dighe's address?

  Pramod Dighe is located at
  Pune, Maharashtra, India

• What is Pramod Dighe's job title?

  Pramod Dighe is a
  WORK EXPERIENCE: 08 Years 05 Months A) Currently working at Fortrea as Senior Functional Quality Specialist from 17-May-2021 till date. B) Worked at Apotex Research Pvt Ltd as Case Reviewer & responsible for Regulatory submissions from 09-Apr-2018 To 07-May-2021. C) Worked with Cipla Ltd Vikhroli Mumbai from 17‐Oct‐2016 To 07-Apr-2018. JOB RESPONSIBILITIES: 1. Worked as Drug Safety Division Mailbox handler, Book-in & Regulatory Reporting Person 2. Worked as Team Member of PV Compliance, Training and Vendor Management Team: • Designing/Review relevant SOPs, WIs/Trainer feedback forms. • Conducting trainings as required for internal and external stakeholders . • Initiation and tracking of Deviations, CAPAs and CRs. • Providing CAPA response and ensuring adherence to timelines for completion of open CAPAs. • Supporting internal and external audits and inspections. • Maintaining Vendor management related documents. • Conducting Post Processing Quality Checks as applicable. • Evaluate/support new vendor identified and support existing vendors. D) Worked with Tata Consultancy Services (Roche Project), Andheri, Mumbai from 28‐Apr‐2015 To 07‐Oct‐2016. JOB RESPONSIBILITIES: Case processing: • Source Document Reviewer: Accountable for handling source documents received via data exchange system and identification of potential adverse event. • Case Manager for IRT Entry: Accountable for handling ICSRs received via data exchange systems, disposition of valid item into ARISG from IRT for further processing in ARISG. • Quality Reviewer for IRT: Accountable for confirming whether IRT data fields are entered against Source document as per applicable guidelines and SOPs. • Narrative writing • Initial and follow up case book in. • Timely follow up with reporter for additional/ missing information • Experience with MedDRA coding, ARISG and ARGUS Safety Database. ACHIEVEMENTS: • ‘Best outgoing student’ award in final year B. Pharmacy (2011‐2012). • ‘Best Outgoing Student’ award in STD 10th (2004‐2005). SKILLS: • Have a good knowledge of case processing, causality assessment, determination of listedness and seriousness, narrative writing • Have a good knowledge in Drug Safety and Pharmacovigilance • Focused approach to work. Sincere & Honest. • Excellent verbal / written communication skills. Team Player. Excellent Management Skills. Labcorp Drug Development

• What industry does Pramod Dighe currently work in?

  Pramod Dighe currently works in the
  Labcorp Drug Development

• What is Pramod Dighe's area of expertise?

  Pramod Dighe specializes in
  WORK EXPERIENCE: 08 Years 05 Months A) Currently working at Fortrea as Senior Functional Quality Specialist from 17-May-2021 till date. B) Worked at Apotex Research Pvt Ltd as Case Reviewer & responsible for Regulatory submissions from 09-Apr-2018 To 07-May-2021. C) Worked with Cipla Ltd Vikhroli Mumbai from 17‐Oct‐2016 To 07-Apr-2018. JOB RESPONSIBILITIES: 1. Worked as Drug Safety Division Mailbox handler, Book-in & Regulatory Reporting Person 2. Worked as Team Member of PV Compliance, Training and Vendor Management Team: • Designing/Review relevant SOPs, WIs/Trainer feedback forms. • Conducting trainings as required for internal and external stakeholders . • Initiation and tracking of Deviations, CAPAs and CRs. • Providing CAPA response and ensuring adherence to timelines for completion of open CAPAs. • Supporting internal and external audits and inspections. • Maintaining Vendor management related documents. • Conducting Post Processing Quality Checks as applicable. • Evaluate/support new vendor identified and support existing vendors. D) Worked with Tata Consultancy Services (Roche Project), Andheri, Mumbai from 28‐Apr‐2015 To 07‐Oct‐2016. JOB RESPONSIBILITIES: Case processing: • Source Document Reviewer: Accountable for handling source documents received via data exchange system and identification of potential adverse event. • Case Manager for IRT Entry: Accountable for handling ICSRs received via data exchange systems, disposition of valid item into ARISG from IRT for further processing in ARISG. • Quality Reviewer for IRT: Accountable for confirming whether IRT data fields are entered against Source document as per applicable guidelines and SOPs. • Narrative writing • Initial and follow up case book in. • Timely follow up with reporter for additional/ missing information • Experience with MedDRA coding, ARISG and ARGUS Safety Database. ACHIEVEMENTS: • ‘Best outgoing student’ award in final year B. Pharmacy (2011‐2012). • ‘Best Outgoing Student’ award in STD 10th (2004‐2005). SKILLS: • Have a good knowledge of case processing, causality assessment, determination of listedness and seriousness, narrative writing • Have a good knowledge in Drug Safety and Pharmacovigilance • Focused approach to work. Sincere & Honest. • Excellent verbal / written communication skills. Team Player. Excellent Management Skills.

• Which languages does Pramod Dighe speak? 

  Pramod Dighe speaks the following languages:
  No languages available.

• Which industries has Pramod Dighe previously worked in?   

  Pramod Dighe has prior experience in the following industries:
  Apotex Research , Cipla , Tata Consultancy Services

• What is Pramod Dighe’s work experience?  

  Pramod Dighe has the following professional experience:
  Labcorp Drug Development , Apotex Research , Cipla , Tata Consultancy Services .

• How can I find Pramod Dighe on LinkedIn?  

  You can view Pramod Dighe’s
  LinkedIn profile at LinkedIn URL.

• What are Pramod Dighe’s work email addresses?  

  Pramod Dighe’s work email addresses are
  [email protected] .

• What company does Pramod Dighe work for?  

  Pramod Dighe works at
  Labcorp Drug Development