Birader Ameen

FAQ About Birader Ameen

• What is Birader Ameen's address?

  Birader Ameen is located at
  Mumbai, Maharashtra, India

• What is Birader Ameen's job title?

  Birader Ameen is a
  Handling of various Clinical Study Documents like DSUR, SUSAR, PSUR, PADER, ACO, HHE, CSR, and Benefit risk analysis report, etc.  Checking of Electronic Submission readiness of documents including References for Regulatory Submission (USFDA and EMEA).  Well versed in Clinical Data Anonymization (Document Redaction and Retaining).  Use of softwares like ERIS and CONNECT as document repository and ISI Publisher, ADLIB and Lorenz Docubridge for Document Publishing.  Well versed with USFDA/ EMEA regulations, ICH-GCP guidelines.  Conversion of ACTD to ICTD.  Performing Document publishing activities of the regulatory documents in scope and other clinical documents to ensure that they are submission ready.  Perform the required activities within the established timelines that are of high quality with adherence to regulatory guidelines and applicable standards, styles, guidelines and processes.  Perform peer review and quality control review of documents within established timelines with adherence to applicable guidelines using appropriate checklists.  Maintain metrics, tracking sheets and training records as per the process requirements. Freyr Solutions

• What industry does Birader Ameen currently work in?

  Birader Ameen currently works in the
  Freyr Solutions

• What is Birader Ameen's area of expertise?

  Birader Ameen specializes in
  Handling of various Clinical Study Documents like DSUR, SUSAR, PSUR, PADER, ACO, HHE, CSR, and Benefit risk analysis report, etc.  Checking of Electronic Submission readiness of documents including References for Regulatory Submission (USFDA and EMEA).  Well versed in Clinical Data Anonymization (Document Redaction and Retaining).  Use of softwares like ERIS and CONNECT as document repository and ISI Publisher, ADLIB and Lorenz Docubridge for Document Publishing.  Well versed with USFDA/ EMEA regulations, ICH-GCP guidelines.  Conversion of ACTD to ICTD.  Performing Document publishing activities of the regulatory documents in scope and other clinical documents to ensure that they are submission ready.  Perform the required activities within the established timelines that are of high quality with adherence to regulatory guidelines and applicable standards, styles, guidelines and processes.  Perform peer review and quality control review of documents within established timelines with adherence to applicable guidelines using appropriate checklists.  Maintain metrics, tracking sheets and training records as per the process requirements.

• Which languages does Birader Ameen speak? 

  Birader Ameen speaks the following languages:
  No languages available.

• Which industries has Birader Ameen previously worked in?   

  Birader Ameen has prior experience in the following industries:
  Siro Clinpharm , Syneos Health , Tata Consultancy Services , Tata Consultancy Services

• What is Birader Ameen’s work experience?  

  Birader Ameen has the following professional experience:
  Freyr Solutions , Siro Clinpharm , Syneos Health , Tata Consultancy Services , Tata Consultancy Services .

• How can I find Birader Ameen on LinkedIn?  

  You can view Birader Ameen’s
  LinkedIn profile at LinkedIn URL.

• What are Birader Ameen’s work email addresses?  

  Birader Ameen’s work email addresses are
  [email protected].

• What company does Birader Ameen work for?  

  Birader Ameen works at
  Freyr Solutions