Sonal S.

Kotkar
Balaji Niwas, Flat No 301/8, Opposite Reliance Fresh
B. T. Kawade, Ghorpadi, Pune - 411001
Mob: +91-8408885038
Email: sonalkotkar1@gmail.com

Professional Experience
Jehangir Clinical Development Center (Contract Term) Aug 2017 – Oct 2018
Senior Clinical Research Co-ordinator & QC, Pune
 Site Identification, Site Selection Visit, site Initiation Visits and conduct Feasibility Studies
in accordance with the protocol and other applicable regulatory guidelines.
 Training of Investigators on Protocol and other applicable regulatory guidelines including
local regulatory guidelines.
 Supervise & maintain Patient Recruitment, Patient Follow-up, and protocol.
 Act as a communication Link between Sponsor and the site by maintaining accurate and
timely sponsor/site correspondence and communication.
 Maintaining Site Monitoring Visit and Site Close-Out Visit in accordance with the
protocol and other applicable regulatory guidelines.
 Updating Site Files, collecting essential and project related documents during the site
visits and maintain Central Clinical File.
 CRF retrieval as per the project instructions. Coordinate and distribute Clinical Study
Material to study sites.

Cognizant Technology Solution Jan 2016 – May 2017

Junior Data Analyst (Pharmacovigilance), Pune
 Receive information on individual case safety reports (Clinical, spontaneous, solicited,
licensee, regulatory & health Authority) and create case files to initialize received safety
reports in safety database.
 Peer review of adverse event (AEs/SAE) reports including report from post-marketing
surveillance or spontaneous in safety database Argus 7.2 for all products.
 Use medical dictionaries such as MedDRA 19.01, WHO-DD & safety narrative
writings and also in maintaining the data as per client specific & SOP’s.
 Identifying clinically relevant information missing from case report & facilitate its
collection (In consultation with medical staff required) by preparing follow-up &
closure of AE related queries with the client or relevant department as applicable.

Jubilant Pharma & Chemical Lab Jan 2015 – Jan 2016

QA Executive, Mumbai
 Creating daily reports based on the day-to-day activities going in the organization.
 Generating clients with the help of tele-conversation from the list provided by the
marketing department.
 Keep a track of the samples sent for the testing & handling change control
Documents.
 Report on product, process and system risks—and keep management informed
 Customer complaints and Required Quotation to customer.
K.D. Pawar College of Pharmacy Sep 2011 – Sep 2012
Lecturer

 Theory periods (Anatomy physiology, Drug store and business Management)

 Practical of subjects (Human anatomy and Physiology, Pharmacology)
 Documentations in office assistance & exams conduction during academics
 To lead and guide students during Industrial tour
 Experience as Practical Reviewer and Approval

Education
 M. Pharm (Pharmaceutics) – 70% 2014
Kamala Nehru College of Pharmacy, Nagpur
 B. Pharm – 62% 2011
Sharad Pawar College of Pharmacy, Nagpur
 D. Pharm – 64% 2007
Priyadarshini Yashodhara College of Pharmacy, Nagpur

Project Profile
M. Pharm Project -“Self-micro emulsifying drug delivery system of water insoluble
Antihypertensive drugs”

Personal Information

Father’s Name : Late Suresh G. Kotkar

Mothers Name : Sanju G Kotkar
Date of Birth : 11 July 1985
Marital Status : Married
Hobbies : Travelling, Dancing & Cooking.

I do hereby declare that the above said particulars are true to best of my knowledge.

Place - Pune

Date - / /2019 (Sonal S Kotkar)