Mohan Elango

FAQ About Mohan Elango

• What is Mohan Elango's address?

  Mohan Elango is located at
  Le Petit-Canada, Le Petit-Canada, Canada

• What is Mohan Elango's job title?

  Mohan Elango is a
  I am worked as Sr. CRA for Novo Nordisk thru Syneos Health. I am worked as CTPS for Bayer thru Brunnel Canada. u2022 Lead the team for assessing and submitting SUSAR reports from Clinical trials Phase I and Phase III (Oncology trials for Biologics) to the regulatory authorities and Ethics committee u2022 Managed and lead the team for writing Safety management plan (SMMP) for Phase III Oncology based trial (Breast cancer studies) u2022 Lead the team for medical review of Individual case reports (ICSRu2019s) for the SUSARu2019S received from clinical trials u2022 Lead the team for developing the annual submission of Developmental safety update (DSUR) reports for the Phase I and Phase III clinical trial SAEu2019s and SARu2019s u2022 Lead the team for quality compliance related to the accuracy, consistency and data reconciliation for the SAEu2019s and SARu2019s from clinical trials and post-marketed ICSRu2019s u2022 Lead the team for the Risk Management Plan (RMP) on the new safety signal detected from clinical trials and marketed products u2022 Lead the team for writing work instructions (WI) and Standard operating procedures for clinical trials u2022 Managed quality review on serious (SAEu2019s) and non-serious adverse events (AE) and assessed seriousness, expectedness of ICSR's from all sources for post-marketing spontaneous, literature, regulatory and Non-interventional study reports u2022 Drafted and managed regulatory submission of periodic safety update reports (PSURs) for EMEA, periodic adverse experience reports (PADER)for US FDA and Canadian annual summary reports(CAR) for Health Canada u2022 Performed signal detection and evaluated the new signal based on ICSRu2019s in the Safety database u2022 Presented the safety issues to the drug safety committee and updated the core safety data profile for the marketed products. Novo Nordisk

• What industry does Mohan Elango currently work in?

  Mohan Elango currently works in the
  Novo Nordisk

• What is Mohan Elango's area of expertise?

  Mohan Elango specializes in
  I am worked as Sr. CRA for Novo Nordisk thru Syneos Health. I am worked as CTPS for Bayer thru Brunnel Canada. u2022 Lead the team for assessing and submitting SUSAR reports from Clinical trials Phase I and Phase III (Oncology trials for Biologics) to the regulatory authorities and Ethics committee u2022 Managed and lead the team for writing Safety management plan (SMMP) for Phase III Oncology based trial (Breast cancer studies) u2022 Lead the team for medical review of Individual case reports (ICSRu2019s) for the SUSARu2019S received from clinical trials u2022 Lead the team for developing the annual submission of Developmental safety update (DSUR) reports for the Phase I and Phase III clinical trial SAEu2019s and SARu2019s u2022 Lead the team for quality compliance related to the accuracy, consistency and data reconciliation for the SAEu2019s and SARu2019s from clinical trials and post-marketed ICSRu2019s u2022 Lead the team for the Risk Management Plan (RMP) on the new safety signal detected from clinical trials and marketed products u2022 Lead the team for writing work instructions (WI) and Standard operating procedures for clinical trials u2022 Managed quality review on serious (SAEu2019s) and non-serious adverse events (AE) and assessed seriousness, expectedness of ICSR's from all sources for post-marketing spontaneous, literature, regulatory and Non-interventional study reports u2022 Drafted and managed regulatory submission of periodic safety update reports (PSURs) for EMEA, periodic adverse experience reports (PADER)for US FDA and Canadian annual summary reports(CAR) for Health Canada u2022 Performed signal detection and evaluated the new signal based on ICSRu2019s in the Safety database u2022 Presented the safety issues to the drug safety committee and updated the core safety data profile for the marketed products.

• Which languages does Mohan Elango speak? 

  Mohan Elango speaks the following languages:
  No languages available.

• Which industries has Mohan Elango previously worked in?   

  Mohan Elango has prior experience in the following industries:
  Novo Nordisk , Bayer , Purdue Pharma (Canada) , NoNO Inc , Johnson & Johnson , Apotex Inc.

• What is Mohan Elango’s work experience?  

  Mohan Elango has the following professional experience:
  Novo Nordisk , Bayer , Purdue Pharma (Canada) , NoNO Inc , Johnson & Johnson , Apotex Inc. .

• How can I find Mohan Elango on LinkedIn?  

  You can view Mohan Elango’s
  LinkedIn profile at LinkedIn URL.

• What are Mohan Elango’s work email addresses?  

  Mohan Elango’s work email addresses are
  [email protected] .

• What company does Mohan Elango work for?  

  Mohan Elango works at
  Novo Nordisk