1. Naveen Pawar
NAVEEN KUMAR PAWAR E-mail: pnaveenkumar20@gmail.com
Pune,India Contact no: +91-7030897089
Summary
 Involved in writing and review ofvarious safetyreports for global regulatorysubmissions for global clients,includingCanadian
Annual Reports (CARs), Addendum Reports (ACOs and Adhocs), Periodic Benefit Risk Evaluation Reports (PBRERs),
Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Bridging reports and other
clinical documents
Education
 M. Sc. (Biotechnology), PondicherryUniversity
 B. Sc. (Biotechnology), Loyola Academy(Osmania University)
Publications, Seminars & Presentations
Naveen Kumar Pawar,N Arumugam. Leafextract of Centratherumpunctatum Cass.exhibits anti-microbial,anti-proliferative
and anti-oxidant properties. Asian journal ofclinical and pharmaceutical research (published July2011).
Work Experience
May 2016 – Present Specialist, Imed Global, Hyderabad
Imed Global (Working for Novartis client)
Medical Writing
• Preparing/Co-authoring safety reports for global regulatory submissions for Imed global clients, including Addendum
Reports,Periodic BenefitRisk Evaluation Reports (PBRERs), Periodic SafetyUpdate Reports (PSURs),Bridging reports
and other clinical documents
• Internal and external (client) communication & co-ordination to get the required inputs
• Generation of line listing from the ARGUS database
• Signal detection and ICSR analysis
• Performing quality checks and implementing new SOP’s for quality improvement
• Training new joiners on authoring various safety reports
• Implementing and promoting use of consistent, efficient and quality processes to meet timelines and deliverables
according to requirements and standard operating procedures and assume accountability for the deliverables
April 2014 – March2016 Medical writer , Sciformix Technologies, Pune
Sciformix (Worked for Johnson and Johnson client)
Safety Writing and Regulatory Affairs
• Preparing/Co-authoring safety reports for global regulatory submissions for Sciformix’s clients, including Canadian
Annual Reports (CARs), Addendum Reports (ACOs and Adhocs), Periodic BenefitRisk Evaluation Reports (PBRERs),
Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Bridging reports and
other clinical documents
• Internal and external (client) communication & co-ordination to get the required inputs
• Generation of line listing from the database
• Well versed with the EU and USFDA regulations
• Timely escalation of unresolved issues to internal & External (client) points of contact
• Tracking and maintenance of metrics, performing and documenting quality checks
• Implementing and promoting use of consistent, efficient and quality processes to meet timelines and deliverables
according to requirements and standard operating procedures and assume accountability for the deliverables
• Resolution on issues affecting project deliverables and timely escalation of unresolved issues to internal and external
(client) points of contact
March2011 – April 2014 Associate Research Analyst, Thomson Reuters, Hyderabad
Thomson Reuters
Custom Information Services (Worked for Takeda client)
• To write Individual Case Safety Report (ICSR) summaries with identifiable patient’s data with suspected or probable

2. adverse drug reaction to one or more medicinal products
• To handle responsibilities of reviewing and processing adverse events reported by investigators, including serious
adverse drug reactions and adverse events from published literature
• Reporting drug-specific adverse events for pharmacovigilance purposes
• Writing patient safety narratives for patients who discontinued due to AEs, SAEs, death or any other event of special
interest
• Quality analysis and review of safety narratives according to client provided guidelines and sources
• To perform the tasks ofmaintaining the safetydatabase and perform coding ofdiseases as wellas adverseevents using
MeSH and MedRA dictionaries
Thomson Reuters
ISI Web of Knowledge platform
• Abstraction and standardized classification of life science data from clinical studies, journals, conferences, patents
and re reviews for the ISI Web of Knowledge platform
• In-depth indexing of major concepts, organisms, taxonomic groups, diseases, genes, pharmaceutical agents and
geographic locations discussed in each document
• Subject coverage: Pre-clinical and clinical research, methodology and instrumentation, environmental and consumer
issues, among others
• Sources: Research articles and reports of original research, review articles, notes, letters, and meta-analyses, books
and book chapters, meeting reports and published abstracts of papers presented at meetings, and United States
patents in life sciences
PERSONAL SKILLS
- Ability to work in team and develop inter-personal skills
- Adaptability to new environment
- Ability to grasp and learn new skills and software quickly
- Good analytical and logical skills
- Excellent oral and communication skills
PERSONAL PROFILE
Name Naveen Kumar Pawar
Gender Male
Nationality Indian
Date of Birth 18th
July 1986
Age 29
Languages known English, Hindi, Tamil and Telugu
DECLARATION
I hereby declare that the above furnished information is true to the bestof my knowledge.
Naveen Kumar Pawar