Amit Kumar is a pharmacovigilance professional with over 6 years of experience. He currently works as an Assistant Manager at Tata Consultancy Services in Pune, India. Some of his key responsibilities include processing and quality reviewing ICSR, legal, and clinical trial cases. He also has experience writing PSUR/PADER/PBRER/DSUR reports. Previously he has worked at Cognizant Technology Solutions and Claris Lifesciences in pharmacovigilance roles. He holds an M.Pharm and B.Pharm from Birla Institute of Technology.

1. Amit Kumar
Contact: +91-9561076789, +91-8793114988
E-Mail: amit2713@gmail.com
Aspiring to scale heights in drug safety reporting as per Regulatory expectations with a Pharmaceutical
organisation of high repute.
Professional Abridgement
∞ A dynamic individual with more than 6 years of experience.
∞ Working in Tata Consultancy Services, Pune, India as an Asst. Manager in Pharmacovigilance Division.
∞ Experience in processing and quality reviewing of ICSR, Legal, and Clinical trial cases.
∞ Experience in PSUR/PADER/PBRER/DSUR writing.
∞ Exceptionally organised with a track record that demonstrates creativity and initiatives to achieve set goals.
∞ Skilfully handled and co-ordinated different bioanalytical, clinical research and drug safety projects.
∞ Experience in setting up of a Pharmacovigilance System for EU and US market.
∞ Monitored Clinical Trials as a sponsor in various CROs. Conducted audit for Clinical trial studies as a sponsor in
CROs.
∞ Initiated Post-marketing surveillance studies.
∞ A proactive learner with a flair for adopting emerging trends & addressing industry requirements to achieve
organisational objectives & profitability norms.
∞ Holds exceptional team spirit thereby helping in easy achievement of organisational & personal goals.
∞ An effective communicator with excellent relationship building & interpersonal skills.
Academe
M.Pharm (Pharmaceutics)
Birla Institute of Technology, Mesra, Ranchi, Jharkhand, India in 2008. Obtained 74.5% marks.
B.Pharm.
Birla Institute of Technology, Mesra, Ranchi, Jharkhand, India in 2006. Obtained 74.0% marks.
Senior Secondary (Science)
C.B.S.E. Board, India in 2000. Obtained 61.4% marks.
Secondary
C.B.S.E. Board, India in 1998. Obtained 69% marks.
Work Experience
TATA CONSULTANCY SERVICES, PUNE, INDIA: 05th
Jul 2012 to till date
• 05th
Jul 2012 to 31st
Mar 2013 as Process Executive (Pharmacovigilance)
• 01st
Apr 2013 to 31st
Mar 2015 date as Business Process Lead (Pharmacovigilance)
• 01st
Apr 2015 to till date as Assistant Manager (Pharmacovigilance) [Mail confirmation received; letter
awaited]
• Perform safety periodic writing including assessment, analysis, and Quality control of all reports
[PBRER/PSUR/DSUR/QR/QSUR/SPR SA].
• Schedule and conduct Kick-off meeting for preparation of report.
• To contribute towards a team in Drug Safety offering Pharmacovigilance services to Clients delivering a
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2. high quality data in stipulated timelines
• Provide technical expertise to Pharmacovigilance/Drug Safety team
• Address Performance Improvement Plans
• Manage and coordinate across Pharmacovigilance/Drug Safety sub-processes (Client specific)
• Ensure compliance to SOPs
• Perform tasks/activities as communicated by the Project Manager.
• Archiving of all safety related documents in EPIC.
• Assist in developing and implementing new techniques in Pharmacovigilance/Drug Safety activities
• Develops strategies in co-ordination with other Team leads and Project Managers so as to meet quality
requirements efficiently and meet timelines set by the client.
- Provide training in:
 The operational techniques and activities undertaken within the Pharmacovigilance/Drug
Safety Unit Amgen Pharmacovigilance/Drug Safety SOPs and other standards
 Undertake training related to a project to Pharmacovigilance/Drug Safety team
members.
• Escalation of identified unresolved issues to Project manager on time
• Ensure that projects are completed as per agreed timelines.
• Interactions and telecons - Coordinate and communicate effectively with primary contacts at Client
teams to ensure satisfactory progress of project work and timely resolution of issues
• Monitor and track SLAs /Metrics on a project basis.
• Act as a gatekeeper for the changes requested to product, service or process (client specific)
• Solid experience and understanding of USFDA regulations, EU regulations, ICH guidelines, GCP
principles, clinical drug development process, organizational, strategic, communication and inter-
personnel skills
Project Involvement:
1. ICSR Case Processing
Reporting to: Assistant Manager
2. Clinical Trial Case Processing
Reporting to: Assistant Manager
3. Pharmacovigilance Standards (Aggregate Report Writing)
Reporting to: Project Manager
- Additional responsibilities (since 14th
Jul 2014): Working as a Subject Matter Expert (Pharmacovigilance).
Tools using at TCS:
1. Argus ver. 7.0
2. EDC Rave
3. MedDRA ver. 17.1
4. EPIC
Notice Period: 3 months
COGNIZANT TECHNOLOGY SOLUTIONS, MUMBAI, INDIA: 03rd
Jan 2011 to 08th
Jun 2012 as Jr. Data Analyst
Job Role: Safety Processing Expert / PSUR writer
• Receive information on adverse events, perform initial checks, search database to prevent duplicate entries,
create case file and initialize received drug safety reports in the DS&E tracking tool and/or safety database
(Argus).
• Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from
source documents including petitions with emphasis on timeliness and quality.
• Evaluate and finish processing of expeditable & non-expeditable AE reports, including review for
completeness and accuracy.
• Use medical dictionaries and business guidances to code medical history, drugs and adverse event terms.
Prepare narratives summarizing the essential details of the case.
• Identify clinically relevant information missing from case report and facilitate its collection (in consultation
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3. with medical staff as required) by preparing follow-up request as needed.
• Alert manager to potential safety signals based on incoming case reports.
• Work with Client’s country safety departments along with US legal processing department, Clinical Safety
Scientists and pharmacovigilance leaders to ensure that reports are accurately collected, evaluated and
databased.
• Assist Cognizant Team manager with related administrative and procedural activities as required or
requested.
• Assists in the training of other Safety Processing Experts as necessary and provide mentorship to new
joinees.
• Writing of quality PSUR within specified timelines as per the Client’s SOPs and and current
Pharmacovigilance regulations and guideline,
• Peer review/QC of PSURs prepared by fellow PSUR writers.
Projects:
1. ICSR Case Processing
a. Reporting to: Team Leader
b. Database: ARGUS ver. 4.2
c. Medical Coding: MedDRA Ver. 13.1
2. Legal Case Processing
a. Reporting to : Service Delivery Manager
b. Database: ARGUS ver. 4.2
c. Medical Coding: MedDRA Ver. 14.1
3. PSUR writing
a. Reporting to: Service Delivery Manager
CLARIS LIFESCIENCES LIMITED, AHEMDABAD, INDIA- as Jr Executive in the Pharmacovigilance division of
I.R.A. deptt: 01st
Jun 2010 to 29 Nov 2010
Job Responsibilities
• Responsible for Pharmacovigilance activity in US market as a team lead at Claris Head Quarter.
• Allocation of daily pharmacovigilance activities and ensure its completion within specified time as per the
current SOPs and regulations.
• Preparation & Review SOPs for Pharmacovigilance.
• Receive ADRs from partners / QPPV / Medical agencies.
• Receive line listing from QPPV and maintain record.
• Designing the protocol, records, procedure for pharmacovigilance for USA in compliance to various
regulatory guidelines.
• Communicate and provide required information to QPPV.
• Processing and reviewing Medwatch 3500A form against the source document.
• Preparation of cover letters for reports submitting to regulatory authorities.
• Preparation of Periodic reports (PSUR/AR/PADER).
• Prepare responses for regulatory queries related to Safety of the products.
• Communicate and establish safety agreement with Partners (US / Canada).
• Collection of safety information from research articles, review papers throughout search engine, journals
and books and inform to relevant department.
• Elaborate understanding and application of MHRA, US FDA and ICH guidelines.
• Assist in initiating Post marketing surveillance study for the company’s products.
• Preparation and maintenance of tracking sheets and reconciliation report.
• Conducting in-house periodic audit for Pharmacovigilance system with respect to expectations described
under US FDA and MHRA guidelines and Good Pharmacovigilance Practices.
• Designing of clinical trial includes reviewing, protocol, case record form and all related
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4. work in compliance to GCP guidelines.
• Monitoring of Clinical trials and BE studies at the Service provider’s site. Periodic visit to the site and
maintaining rapport between Company, Investigators, and Volunteers.
• Conduct in-process and documentation audit at CROs as a sponsor of the study.
RANBAXY LABORATORIES LIMITED, as Research Associate – Clinical Pharmacology and
Pharmacokinetics: 30 Sep 2008 to 20 May 2010
• Development and maintaining GLP compliance in Bio-analytical laboratory and conduct all experiments in
conformance to SOPs and current regulations to produce quality data.
• Coordinate effective planning, set-up, management and closeout of clinical trials in order to meet the applicable
GCP/GLP standards.
• Ensure effective technology transfer during the analytical and bioanalytical methods between the R&D and allied
company (Terapia Ranbaxy) or CROs.
• Support the senior management with the organizational activities of clinical trial management.
• Prepare and review of technical documents, including response to QA audits, Method Validation reports, study
forms (Raw Data Sheets) for error free Bio-analytical methods.
• Develop and Validate cost effective, reproducible and rugged bioanalytical method for the determination of
analyte(s) in biological matrix for the bioequivalence studies and write method SOP for the same.
• Process and analyze biological samples using LCMS/MS system.
• Online documentation of each and every activity as per the current SOPs, GLP and regulatory guidelines.
• Databasing each result in Nugenesis Database.
• Coordinating different bioanalytical assigned projects and maintaining the timelines for each activity viz. method
development, validation and analysis.
Certifications and Awards
 Recipient of BPS-Performance Linked Reward on 23 Jan 2014 from Tata Consultancy Services for
outstanding contribution in the Organization.
 Recipient of BPS-Performance Linked Reward on 03 Sep 2014 from Tata Consultancy Services for
outstanding contribution in the Organization.
 Received Process Excelentia Award for Quarter-2 2011 from Cognizant for quality performance in ‘Novartis
Legal Case Processing’.
 Received Opel Award 2011 from Cognizant for outstanding performance, productivity and dedicated service.
 Qualified GATE 2006 with 95.4 percentile.
Workshop/Seminars attended
1. Title : Monolithic Columns- Applications (2009)
Organised by: Merck Ltd
Venue : New Delhi.
2. Title : The SME (Subject Matter Expert) Career Path Program (14th – 16th Jul 2014)
Organized by: Tata Consultancy Services
Venue: Mumbai
• Attended 56th Indian Pharmaceutical Congress (2004), Kolkata, India.
Academic Projects Handled
M. Pharm.
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5. Project Title: Effect of Diluents on solid- state Stability and Thermal Behaviour of Ibuprofen
B. Pharm.
Project Title: Application of the Concept of Osmotic Pressure in the Development of Osmotic Pump
Unique Drug Delivery Device.
Computer Proficiency
MS Tools: MS Word, MS Excel, MS Powerpoint
Data Analysing Programs: Analyst software (Version 1.4.0 and 1.4.1), TA 60,
Graph Pad Instat, Graph Pad Prism
Operating Systems: Windows XP/Vista/ Windows 7
Database: ARGUS 5.1, Nugenesis, EDC Rave
Medical coding tools: MedDRA, WHO Drug Dictionary, ICD-9
Personal Dossier
Date of Birth: 27th
January, 1983
Address for communication: S/O Sri Ganesh Saw, Quarter Number: 3-112, Sector: 2A, Bokaro Steel City- 827001
(Jharkhand) India
Permanent Address: At- Telmunga, Post- Kasmar, Distt. Bokaro PIN- 829115 (Jharkhand), India
I hereby declare that the particulars mentioned above are correct to the best of my knowledge and belief.
Date: 08 May 2015
Place: Pune, India Amit Kumar
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6. Project Title: Effect of Diluents on solid- state Stability and Thermal Behaviour of Ibuprofen
B. Pharm.
Project Title: Application of the Concept of Osmotic Pressure in the Development of Osmotic Pump
Unique Drug Delivery Device.
Computer Proficiency
MS Tools: MS Word, MS Excel, MS Powerpoint
Data Analysing Programs: Analyst software (Version 1.4.0 and 1.4.1), TA 60,
Graph Pad Instat, Graph Pad Prism
Operating Systems: Windows XP/Vista/ Windows 7
Database: ARGUS 5.1, Nugenesis, EDC Rave
Medical coding tools: MedDRA, WHO Drug Dictionary, ICD-9
Personal Dossier
Date of Birth: 27th
January, 1983
Address for communication: S/O Sri Ganesh Saw, Quarter Number: 3-112, Sector: 2A, Bokaro Steel City- 827001
(Jharkhand) India
Permanent Address: At- Telmunga, Post- Kasmar, Distt. Bokaro PIN- 829115 (Jharkhand), India
I hereby declare that the particulars mentioned above are correct to the best of my knowledge and belief.
Date: 08 May 2015
Place: Pune, India Amit Kumar
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