Namdev Kale

FAQ About Namdev Kale

• What is Namdev Kale's address?

  Namdev Kale is located at
  Pune, Maharashtra, India

• What is Namdev Kale's job title?

  Namdev Kale is a
  Signal detection and evaluation: Supports PV activities for a product, or group of products in partnership with the Global Safety Officer (GSO) to evaluate safety data and signals for assigned company products, • Support GSO safety related activities for assigned company products and manage ongoing core signal detection activities for GSO review. • Evaluate safety data from multiple sources Author periodic signaling reports • Coordinate, author and propose responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with GSO • Support the preparation and maintenance of safety sections of the Company Core Data Sheet • In partnership with the GSO, provide strategic input and review of applicable sections of the PBRER and DSUR to ensure that aggregate data analyses are consistent with overall product safety profile • Provide safety content for new drug applications and other regulatory filings including review of the safety and support to GSO for benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation • Collaborates with the GSO in preparation and authoring developmental Risk Management Plans (DRMPs), safety sections of the EU Risk Management Plan (RMPs) and Risk Evaluation and Mitigation Strategy Plans (REMS). • Represents Pharmacovigilance on study teams, cross functional product teams, etc. when assigned as the delegate for the GSO 2. Authoring: The primary responsibilities include lead/authoring/reviews/coordination as well as the QC of the literature/Aggregate reporting. • Serves as principal owner of the Global aggregate report deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. • Lead author and finalizes aggregate reports, including but not limited to PBRERs, DSURs, PADERs, RMPs, ACOs, and six monthly line listings; Iqvia Rds

• What industry does Namdev Kale currently work in?

  Namdev Kale currently works in the
  Iqvia Rds

• What is Namdev Kale's area of expertise?

  Namdev Kale specializes in
  Signal detection and evaluation: Supports PV activities for a product, or group of products in partnership with the Global Safety Officer (GSO) to evaluate safety data and signals for assigned company products, • Support GSO safety related activities for assigned company products and manage ongoing core signal detection activities for GSO review. • Evaluate safety data from multiple sources Author periodic signaling reports • Coordinate, author and propose responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with GSO • Support the preparation and maintenance of safety sections of the Company Core Data Sheet • In partnership with the GSO, provide strategic input and review of applicable sections of the PBRER and DSUR to ensure that aggregate data analyses are consistent with overall product safety profile • Provide safety content for new drug applications and other regulatory filings including review of the safety and support to GSO for benefit risk sections, review and preparation of relevant safety sections to ensure consistency across documents and support response preparation • Collaborates with the GSO in preparation and authoring developmental Risk Management Plans (DRMPs), safety sections of the EU Risk Management Plan (RMPs) and Risk Evaluation and Mitigation Strategy Plans (REMS). • Represents Pharmacovigilance on study teams, cross functional product teams, etc. when assigned as the delegate for the GSO 2. Authoring: The primary responsibilities include lead/authoring/reviews/coordination as well as the QC of the literature/Aggregate reporting. • Serves as principal owner of the Global aggregate report deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements. • Lead author and finalizes aggregate reports, including but not limited to PBRERs, DSURs, PADERs, RMPs, ACOs, and six monthly line listings;

• Which languages does Namdev Kale speak? 

  Namdev Kale speaks the following languages:
  No languages available.

• Which industries has Namdev Kale previously worked in?   

  Namdev Kale has prior experience in the following industries:
  Apcer Life Sciences , Tata Consultancy Services , Tata Consultancy Services , Macleods Pharmaceutical , Macleods Pharmaceutical

• What is Namdev Kale’s work experience?  

  Namdev Kale has the following professional experience:
  Iqvia Rds , Apcer Life Sciences , Tata Consultancy Services , Tata Consultancy Services , Macleods Pharmaceutical , Macleods Pharmaceutical .

• How can I find Namdev Kale on LinkedIn?  

  You can view Namdev Kale’s
  LinkedIn profile at LinkedIn URL.

• What are Namdev Kale’s work email addresses?  

  Namdev Kale’s work email addresses are
  [email protected] .

• What company does Namdev Kale work for?  

  Namdev Kale works at
  Iqvia Rds