Summary
Overview
Work History
Education
Skills
Interests
Timeline
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Dr Avinash R.  Kakade

Dr Avinash R. Kakade

MBBS, MPhil, PMP
Mumbai,MH

Summary

Performance-driven medical doctor with 21 years of experience aligning systems with business requirements, policies and regulatory requirements. Passionate about applying excellent organization and communication skills to manage and lead teams. Results-oriented individual well-versed in interfacing and consulting on business processes to drive results based on sound overall business judgment.

Overview

22
22
years of professional experience
17
17

Years of pharmaceutical medicine experience

4
4
Languages

Work History

Vice President, Head Pharmacovigilance

Cipla Ltd.
Mumbai, Maharashtra
10.2021 - Current
  • Oversein hiring, adding valuable, talented professionals to strengthen global pharmacovigilance team.
  • Core team member for product recall and all medicolegal cases.
  • Spearheading cross-functional collaboration across departments to achieve training and compliance.
  • Resolved issues and recommended actions based on production and compliance reports.
  • Established performance goals for department and outlined processes for achievement.
  • Identified and resolved issues between employees, promoting better collaboration and mutual respect.
  • Demonstrated proficient leadership skills to motivate employees and build competent teams.
  • Collaborated with senior management to develop strategic initiatives and long term goals.
  • Mitigated regulatory risks by overseeing adherence to safety regulations.
  • Increased workflow by analyzing data and maximizing opportunities for improved productivity across several areas.

Senior General Manager, Global Head of DSRM

Lupin Ltd.
Mumbai, Maharashtra
06.2019 - 10.2021
  • Led the global PV team including operations and compliance and the insourced contractors.
  • Identified and recommended areas for improvement in processes with targeted solutions.
  • Maintained quality through training and coaching during daily activities.
  • Controlled and enforced standard operating procedures and compliance with regulations.

Senior Director, Head PV

Cipla Ltd.
Mumbai, Maharashtra
05.2017 - 06.2019
  • Devised cost efficient processes resulting in reduction in pharmacovigilance costs by approximately 20% while improving quality, compliance and productivity.
  • Increased team morale and increased rigor on the floor by reducing internal strife
  • Being a problem-solver leader with an ability to organize people and systems together, I managed to reduce attrition in pharmacovigilance team to single digits in one year at Cipla
  • I streamlined SOPs after interacting with a regulatory agency leading to reduction in the pharmacovigilance case volumes by 28 to 30 percent
  • Drafted PV plan; first of it's kind for Cipla in 2018 to expand PV in emerging markets
  • Streamlined pharmacovigilance QMS (quality management system) making it more compliant thus reducing the number of deviations and CAPAs leading to enhanced inspection readiness of the team
  • Integral part of all medicolegal and product recall cases

Senior Manager, Global Regulatory and Safety

Amgen Ltd
Mumbai, Maharashtra
09.2012 - 04.2017
  • Implemented productivity benchmarks across all outsourced vendors to maximize outsourcing revenue.
  • Maintained frequent interaction with senior management of vendors to measure goal achievement and determine areas of improvement.
  • Provided strong leadership to enhance team productivity and morale.
  • Strategy Development – planning and executing a new safety outsourcing opportunity, finalizing agreements including negotiations for unit costing of the safety work to be outsourced(SOWs/SDEAs), troubleshoot start-up issues, create SLA and KPI metrics, build robust governance structure and relationship management plan with the suppliers, contribute in RFIs/RFPs and vendor selection
  • Operations Management – responsible for managing 11 long-term safety projects (medical review, case management, periodic aggregate reports and maternal safety) involving staff of 400 members and valued at 10 million USD across global safety vendors, conduct interviews of supplier staff, help in developing retention plans, meet the vendor teams on regular basis (pep-talk, touch base, source feedback), develop and assist in process improvements with an aim to make the process efficient and lean
  • Received 5 Bravo awards

General Manager, Pharmacovigilance

Accenture Ltd
Bengaluru, Karnataka
04.2012 - 09.2012
  • Led pharmacovigilance operations for case management and medical review activities for one client of Accenture (one of top 3 pharmaceutical companies worldwide) – led a team of 80 plus associates (medical reviewers and case processors).
  • Subject matter expert for the engagement; contributed to training, process improvements, RCA and CAPA documentation.
  • Successfully led the performance, consistency, turn-around time and quality of the deliverables.

Pharmacovigilance Officer

Aspen Global Incorporated
Grand Baie, Mauritius
03.2011 - 03.2012
  • Pharmacovigilance lead for the company
  • Led the day to day global pharmacovigilance operations including but not limited to Safety data exchange agreements with affiliates and distributors, responding to queries from regulators, core and local label updates, periodic reports medical and safety review, signal detection and risk management – chairing and conducting monthly safety meetings, vendor monitoring and safety data migration including data mapping and helping IS team install the new safety database

Senior Pharmacovigilance Physician

Sciformix Ltd
Mumbai, Maharashtra
03.2008 - 02.2011
  • Performed medical review of cases and aggregate reports
  • Led a Phase IIb SAE project and presented in Investigators meeting in USA in 2009
  • Recipient of Employee of the Quarter.

General Physician

Practice in community and hospitals
Mumbai, Maharashtra
01.2002 - 12.2007
  • Teamed with other physicians, specialists and health care providers to provide well-rounded care for complex cases.
  • Evaluated patient histories, complaints and current symptoms and provided treatment

Education

MBBS - Medicine

Topiwala National Medical College
Mumbai
07.1996 - 10.2001

MPhil - Biostatistics

The Global Open University
Nagaland
12.2008 - 03.2012

PMP - Project Management

Project Management Institute
USA
01.2016 - 01.2016

Lean Six Sigma Green Belt - Lean Six Sigma

KPMG
Mumbai
05.2014 - 05.2014

Executive Program in Strategic Management - Strategic Management

IIM Rohtak
Rohtak
08.2017 - 05.2018

Black Belt Six Sigma - Six Sigma

Simplilearn
Bangalore
12.2016 - 12.2016

Skills

    Medical Science, Patient care

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Interests

CSR activities

Cooking

Timeline

Vice President, Head Pharmacovigilance

Cipla Ltd.
10.2021 - Current

Senior General Manager, Global Head of DSRM

Lupin Ltd.
06.2019 - 10.2021

Executive Program in Strategic Management - Strategic Management

IIM Rohtak
08.2017 - 05.2018

Senior Director, Head PV

Cipla Ltd.
05.2017 - 06.2019

Black Belt Six Sigma - Six Sigma

Simplilearn
12.2016 - 12.2016

PMP - Project Management

Project Management Institute
01.2016 - 01.2016

Lean Six Sigma Green Belt - Lean Six Sigma

KPMG
05.2014 - 05.2014

Senior Manager, Global Regulatory and Safety

Amgen Ltd
09.2012 - 04.2017

General Manager, Pharmacovigilance

Accenture Ltd
04.2012 - 09.2012

Pharmacovigilance Officer

Aspen Global Incorporated
03.2011 - 03.2012

MPhil - Biostatistics

The Global Open University
12.2008 - 03.2012

Senior Pharmacovigilance Physician

Sciformix Ltd
03.2008 - 02.2011

General Physician

Practice in community and hospitals
01.2002 - 12.2007

MBBS - Medicine

Topiwala National Medical College
07.1996 - 10.2001
Dr Avinash R. KakadeMBBS, MPhil, PMP