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Pavan Kulkarni



Joined Jan 21 2013
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General Info

MALE
39 years old
Sydney
Site Memberships


Do I have an Australian Visa or am I already living in Australia?

Yes

Have I applied for an Australian visa or residency?

Yes

Do I require sponsorship?

No

What is my biggest challenge with finding employment in Australia?

I have found many challenges with respect to finding a job in Australia.

1) Local experience

2)Skills do not match


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Pavan Kumar Kulkarni

3 Botany Street, Randwick, Sydney, NSW - 2031

Telephone: +61 404138333 Email: pavan0505@gmail.com

 

Project Lead – Clinical trials and Resource Management

 

 Versatile and resourceful international project management professional offering over 7 years’ experience in managing Projects & Resources along with developing Strategies for Global clinical trial management for the Pharmaceutical industry.

 Demonstrated ability to Liaise with various internal and external customers (Clinical team, QA, BPA, Medical sales and vendors) for successful completion of assigned projects

 Creative strategist and an effective planner with extensive knowledge of Clinical Supplies & related IT applications and excellence in translating & integrating business & technology needs.

 A Certified Project Management professional with expertise in implementing Resource based projects and developing Packaging designs of Kits and clinical labels in accordance with the ICH-GCP & GMP guidelines for Global Clinical trials (considering patient recruitment strategies at each site)

 Skilled in leading Project Transformations and utilizing Pharmaceutical Knowledge, Strategic Insight and Sharp Planning Skills to manage Business Operations and business objectives.

 Extensive knowledge in Lean implementation on Clinical Labelling & Documentation Application, Validation & Rollout Planning, Process Design and Labelling Software in Drug Supply Management through process optimization.

 Subject Matter Expert conversant with the intricacies of the study protocol.

 Outstanding track record in serving as a Change Leader & Focal Point for Resource Planning; undertaking extensive process improvement strategic initiatives in compliance with the project & Global organizational objectives.

 Recognized for hands-on experience in performing Pre-QA & GMP checks on the Translation Database and random packaging documentation including label designs & pack designs.

 An excellent communicator - with demonstrated ability to lead & train Global teams and interact with people of diverse ethnicities and comfortable working in a multi-cultural set-up.

 

CORE COMPETENCIES

 

Project Management ▪ Clinical Supplies management ▪ Line Unit Checks ▪ Randomization ▪ Resource Management ▪ Clinical Labelling & Packaging ▪ Business Process Modelling ▪ Performance Benchmarking & Process Driven Initiatives ▪ Global Team Communication ▪ Lean Projects ▪ Inventory management ▪ Materials management ▪ Forecasting and Supply planning

 

KEY ACHIEVEMENTS ACROSS CAREER SPAN

 

 Spearheaded the implementation of Clinical trial supplies department and print shop for printing single panel, multi-panel and booklet label in Fisher Clinical Services (A Thermo Fisher Scientific Company) Ahmedabad.

 Resource Planning and Performance network Lead for Clinical supplies group, Novartis, Hyderabad

 Leading Global Line unit review activity from India

 Lead mapping of Key DSM Processes in Mega Tool for Clinical supplies labelling and packaging group, Novartis, Hyderabad thereby contributing for process improvement and further simplification of process

 Lead Vendor, Internal QA, Client and Health authority audits in Jubilant Biosys Ltd, Bangalore, Fisher Clinical Services, Ahmedabad and Novartis HealthCare Pvt Ltd, Hyderabad

 

CAREER PROGRESSION

 

Associate Manager – Clinical Supplies Documentation April 2010- Dec 2012

Drug Supply Management – TRD (Technical Research & Development)

Novartis HealthCare Pvt Ltd, Hyderabad, India

 

Multinational pharmaceutical company with core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health

 

 Calculating Key Performance Indicators of Drug Supply Management - India and presenting it to Global Performance network team and to take necessary actions to improve performance – Quality and Productivity

 DSM process simplification and improvement

 Business Lead DSM - Planning tool

 Interview, hire and train talents on various Drug Supply Management processes.

 Devising process improvement initiatives and establishing communication strategy for assigned strategic projects

 Developing communication platforms & tools in conjunction with stakeholders.

 Collaborating with cross functional teams including departmental planners & strategic project leaders to ensure project implementation in compliance with Global DSM objectives.

 Identifying benchmarks and best practices and working on SAP implementation across Supply Chain.

 Leading resource planning and Global Line Unit team and also internal QA and HA audits

Senior Specialist – Clinical Supplies Documentation Nov 2009- Mar 2010 Drug Supply Management – TRD (Technical Research & Development)

Novartis HealthCare Pvt Ltd, Hyderabad, India

 

Multinational pharmaceutical company with core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health

 

 Lead tactical planning meeting from Drug Supply Management – India to help Global DSM Clinical packaging operations soft planning

 Implemented process for Japan Randomization and ECB cards printing and shipment

 Played a significant role in establishing the documentation group and participated in the roll out of tools

 Lead Key DSM Process Mapping in Mega Tool for Clinical supplies labelling and packaging group, Novartis, Hyderabad thereby contributing for process improvement and further simplification of process

 Performed Line Unit checks for GMP documents and peer review for the colleagues

 Evaluated and aligned KPI’s for Clinical supplies documentation group in Hyderabad

 Interviewed, hired and trained new talents on various Drug Supply Management processes.

 Lead internal QA and HA audits

 

Assistant Project Manager – Client Services Feb 2009 – Nov 2009

Fisher Clinical Services, Ahmedabad, India,

 Established Clinical supplies labeling set-up process and established print shop for printing single panel, multi-panel and booklet labels (variable data)

 Instrumental in defining clinical label material movement and planning and designing of print-shop

 Defining label specification including size, type and text for open and blinded studies

 Plan and manage external service providers and clients

 Performed validation activities on CTSM system and vendor qualification for clinical supply label local procurement

 

Executive – Clinical Supplies Documentation Jan 2008 – Jan 2009

Novartis Healthcare Pvt. Ltd. Hyderabad, India

 

Multinational pharmaceutical company with core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health

 

 Accountable for Clinical supplies project management following clinical trial protocol and various country regulations successfully liaising with Drug regulatory affairs, Packaging operations and Study Managers.

 Played a significant role in establishing the documentation group and participated in the roll out of tools

 

Research Associate

Jubilant Biosys Ltd, Bangalore, India Oct 2005 – Dec 2007

 Project involved creating strategies for building complete and effective digital information environment from scientific literature mining for scientific research and Drug Discovery

 

EDUCATIONAL QUALIFICATIONS

 

Masters in Biotechnology (First Class) 2003 - 2005

Presidency College, Bangalore University

 

B.Sc. In Chemistry, Zoology and Microbiology (First Class) 2000 - 2003

BHS First Grade College, Bangalore University

 

Core Project Management Concepts – 14 Professional development units Dec - 2009

Sponsored by Novartis Pharmaceuticals, Hyderabad – India

 

PERSONAL DETAILS

 

Date of Birth: 5th May 1981, Nationality: Indian, Gender: Male, Marital Status: Married, Languages Proficiency: English, Kannada, Telugu, Hindi

 

References available on request