MS Team
Anand Kharade
Process Expert - PV Domain Consultant Team
Mumbai/Navi Mumbai/Thane
Summary
Versatile SME and business analysis practioneer with analytical skillset and knowledge of drug regulatory affairs, drug safety services, business growth and transformation, sales enablement and drug safety operational areas.
Transitioning into actual business analysis coupled with Agile mindset by embracing adaptable approach to shift aspiration from business services to solution development, automation, business transformation being a change agent.
Practiced domain consulting and problem-solver with more than 6 years of experience in lifescience having 13+ years of overall industry experience.
Ready to accept a challenge by broadening domain knowedge in different business analyst (BA) roles for change with an objective to reach till highest role in Business analysis all knowledge areas; Principal BA.
Overview
20
20
years of professional experience
9
9
years of post-secondary education
6
6
Certifications
5
5
Languages
Work History
Process Expert
Tata consultancy services
Mumbai
07.2015 - Current
- Leverage business analysis practices and KANBAN for pharmacovigilance related sales assets development for sales enablement - Case study, consultative pitch, white paper, matrix, infographs and PoV.
- Apply subject matter expertise to improve process.
- Support to content development and implementation of forthcoming relevant regulatory changes.
- Handle RFI and RFP with team to generate business.
- Key inputs for safety database development for a client.
- Develop and review E0 and E1 level pharmacovigilance training content.
- Identify and recommend a relevant functionality business spot or business opprtunity with analytical evidence to PV lead.
- Key inputs for "VMB" Value messaging brief.
- Coordinate with corporate marketing and content team members for sales asset publication.
- Develop search strategy for monitoring stringent drug regulatory agencies and other allied organization's for regulatory insights.
- As a primary SME support domain consultant team by monitoring, analyzing relevant regulatory updates not limited with functionality trend analysis, market and industry trend analysis, PV relevant solution analysis and key competitor analysis of pharmacovigilance service provider who are at leaders quadrant
- Vigilant towards new and revised relevant regulatory updates.
- Maintaining and grooming learning hub of pharmacovigilance functionality.
Work Process Expert
Tata consultancy services
Mumbai
08.2014 - 07.2015
- Onboarded analysis temps for regulatory update.
- Generate business focus analysis report.
- Led projects and analyzed collated data to map a projects by identifying opportunities for improvement.
- Develop consultative methodology.
- Identify relevant secondary source data.
- Handle RFI and RFP with a team to generate business.
- Exceeded goals through effective task prioritization and great work ethic.
- Identified issues, analyzed information and provided solutions to problems.
- Coordinate with operations and collate a relevant quantifiable data to update pharmacovigilance capability.
- Collaborated with team members to achieve target results.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Developed and maintained courteous and effective working relationships.
- Actively listened to operational SPOCs, confirming full understanding before addressing concerns.
- Upskilling and strengthening competency through inhouse learning and development extending to external courses and certifications.
Process Executive
Tata consultancy services
Mumbai
05.2012 - 07.2014
- Spearheaded organizational development efforts, incorporating macro-level business process enhancements.
- Handle spontaneous and non spontaneous ICSR
- Extract adverse events and relevant information in to the Argus drug safety database
- Handle ePMO tool
- MedDRA and WHO DD coding
- Investigated basic issues and escalated more complicated concerns.
- Ensure timely submission of ICSR to DRA.
- Collaborated with peers to measure ongoing process performance, enacting changes based on historical data.
- Strictly follow company policy
- Analyzed and identify opprtunity to shifting towards business development.
- Participate in meetings and training to maintain interdisciplinary communication of process weaknesses and performance.
Manage End to End International Drug Registration
Aaheli healthcare Pvt. Ltd.
New Mumbai
01.2012 - 05.2012
- Handle end to end international drug registration procedure for company's first pipeline products within product portfolio for new entry into "Eastern european market (Moldova)"; "Asian market (Philippine) "; "African market (Mali)".
- Coordination for procurement of requirements for registration
- Maintain, prioritizing and execution registration by communication with international marketing director (Act as a external consultant) to capture market and generate business.
- Provide product quotation to potential prospect under observation of technical director and through international marketing director.
- Key inputs for artwork development as per respective regulatory guideline.
QA and Regulatory Affairs
IDA Trading Foundation PVT. LTD.
South Mumbai
06.2010 - 01.2012
- Dossier for ROW countries as per EU guideline.
- Training on JD Edward ERP application.
- Query reply to respective DRA.
- Variation submission for medicinal product.
- Support with international tender requirements like CHAI and / or Gates foundation etc.
- Collating data to perform "Trend analysis".
- Work instruction and regulatory updates of JD Edward under observation.
- Active participation in external trainings recommended by organization.
Executive Regulatory Affairs
Prime Pharmaceutical Ltd.
Mumbai suburb
12.2009 - 06.2010
- Active participation in the client meeting with organizations promoter and other team member to understand requirements.
- Dossier for semiregulated and non regulated drug market as per country specific guideline including ACTD format.
- Review primary and secondary packing material as per country specific guideline.
- Collaboration with respective stakeholders for procurement of registration requirements.
- Actively participate in company initiative of ISO 9001 : 2008 certificate.
Jr. Executive - Regulatory Affair
SRS Pharmaceuticals PVT. LTD.
South Mumbai
03.2007 - 12.2009
- Dossier for non regulated market.
- Prepare and validate of MSDS for product registration.
- Participate in kickoff meeting for customized solution development for organization to provide FDA licensing expertise.
- Attend international CPHi exhibition to explore and gain relevant insights.
Executive - International Registration
SRS Pharmaceuticals PVT. LTD.
Mumbai suburb
03.2007 - 12.2009
- Liaison with ROC, FDA, EPC and foreign language translation agency.
- Mentoring new entrant for liasioning.
- Collaboration to procure process validation from external laboratory.
- Check primary and secondary packaging material.
- Develop and garnishing business relationship with drug regulatory authorities at different level in Mumbai.
- Support for Asian authority audit and inspection of a manufacturing plant.
Management Staff
Cipla Ltd.
Mumbai suburb
11.2004 - 08.2006
- Develop and foster liaisoning business relationship with drug regulatory authority (FDA) and other FDA staff at Mumbai.
- Compile and submission of application to procurement FDA documents like COPP, FSC etc.
- Maintain and organize FDA documents like product license, COPP and WHO-GMP certificate.
- Participate in UNICEF requirements.
- Procure method of analysis from quality control laboratory for FDA application as one of essential requirement to procure product license.
- Represent a company by providing requested medicinal products to FDA as corporate social responsibility.
Education
No Degree - SSC + Turning Technical Subject
Elphinstone Technical High School
South Mumbai , India 06.1995 - 03.1996
No Degree - HSC +Vocational Subject (Mechanical Maintenance)
Elphinstone Technical Higschool And Junior College
South Mumbai, India 06.1998 - 03.1999
Diploma in Pharmacy - Pharmacy
Nagrik Shikshan Sanstha's College of Pharmacy
South Mumbai, India 02.1999 - 02.2001
Bachelor of Pharmacy - Pharmacy
Smt. S. S. Patil Collage of Pharmacy
Maharashtra State, India 06.2001 - 04.2004
MBA - Marketing
Ulyanovsk State University
Ulyanovsk, Russian Federation 12.2013 - 12.2014
PGDM-MM-HB - Marketing Management
Welingkar Institute of Management
Mumbai City, India 12.2015 - 12.2017
Skills
Analytical thinking skill
undefinedCertification
Certified Business Process Mapping Associate
Affiliations
- Indian Institute Business Analysis (IIBA)
- All India Management Association (AIMA)
- Maharashtra State Pharmacy Council (MSPC)
- Indian Pharmacist Graduate Association (IPGA)
- Indian Pharmacist Association (IPA)
Software
Google chat
Zoom
Webex
Argus drug safety
Jile
Jira
JD Edward
E PMO
MS Office 360
Ultimatix
Digital store application
Prime Hub
Accomplishments
- Product Specialist Programme (PSP - Business Analysis)
- Business Analysis Practionner Programme (BAPP)
- Special Initiative Award
- Learning Achievement Award (Twice)
- Selection to contribute for TCS -Business Domain Academy under Erudite Programme
- SME Career Path Programme
- Rank holder in academic
Additional Information
- Certificate in german language (Mumbai university) equivalent to A1.
- Certificate course in CRM (TCS BDA).
- Corporate grooming and etiquette by Sabira Merchant (Princeton academy).
- Time management (Princeton academy).
- Certificate in marketing management - capturing marketing insights (Alison).
- Diploma in Business Communications (Alison).
- Professional certificate in Research and Design (PCRSD) - Metropolitan School of Business and Management London
- International Business Environment and Global Strategy - IIMBx
Timeline
PGDM-MM-HB - Marketing Management
Welingkar Institute of Management
12.2015 - 12.2017
Process Expert
Tata consultancy services
07.2015 - Current
Work Process Expert
Tata consultancy services
08.2014 - 07.2015
MBA - Marketing
Ulyanovsk State University
12.2013 - 12.2014
Process Executive
Tata consultancy services
05.2012 - 07.2014
Manage End to End International Drug Registration
Aaheli healthcare Pvt. Ltd.
01.2012 - 05.2012
QA and Regulatory Affairs
IDA Trading Foundation PVT. LTD.
06.2010 - 01.2012
Executive Regulatory Affairs
Prime Pharmaceutical Ltd.
12.2009 - 06.2010
Jr. Executive - Regulatory Affair
SRS Pharmaceuticals PVT. LTD.
03.2007 - 12.2009
Executive - International Registration
SRS Pharmaceuticals PVT. LTD.
03.2007 - 12.2009
Management Staff
Cipla Ltd.
11.2004 - 08.2006
Bachelor of Pharmacy - Pharmacy
Smt. S. S. Patil Collage of Pharmacy
06.2001 - 04.2004
Diploma in Pharmacy - Pharmacy
Nagrik Shikshan Sanstha's College of Pharmacy
02.1999 - 02.2001
No Degree - HSC +Vocational Subject (Mechanical Maintenance)
Elphinstone Technical Higschool And Junior College
06.1998 - 03.1999
No Degree - SSC + Turning Technical Subject
Elphinstone Technical High School
06.1995 - 03.1996
Similar Profiles
Vrunda ChindhadeVrunda Chindhade
HR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services LimitedHR Manager at Tata Consultancy Services, TCS, Tata Consultancy Services Limited
Sreya BasuSreya Basu
Procare Analyst at Tata Steel(Tata Consultancy Services)Procare Analyst at Tata Steel(Tata Consultancy Services)
Arun VArun V
Program Manager at Tata consultancy services | Financial Ombudsman ServicesProgram Manager at Tata consultancy services | Financial Ombudsman Services
Naimish AgnihotriNaimish Agnihotri
Assistant Delivery Manager at Tata Consultancy Services, Global Shared ServicesAssistant Delivery Manager at Tata Consultancy Services, Global Shared Services
Raviraj UghadeRaviraj Ughade
Network Engineer at Progenesis IVF PVT LTDNetwork Engineer at Progenesis IVF PVT LTD