SMITA SUTAR (AVHAD) (M.PHARM)
E-mail : smita_avhad22 AT rediffmail.com
CAREER OBJECTIVE :
To contribute positively and productively towards the growth of the organization and being a part of the organization with acquired expertise, creative talents and commitment to excellence. Desire a position with career growth potential.
WORK EXPERIENCE :
Currently working as Senior Process Associate at Tata Consultancy Services, Pune, India (Jan-2014 to present)
Functional Area :Drug safety & Pharmacovigilance
Job Responsibilities :
** Accountable for handling ICSRs, disposition of valid items from IRT to ARISg for further processing
** Acknowledging receipt of ICSR
** Responsible for generating and forwarding appropriate queries and request for clarification of discrepant data or additional data
** Handling invalid items in to IRT using reference documents
** Identifying duplicate/invalid ICSR in ARISg and handling as per relevant SOP
** Accurate data capture of Spontaneous/Clinical ICSR
** Clinical assessments which includes case seriousness
** Adverse event labeling with the use of Investigator Brochure (IB), CDS, EU-SPC and US Package Inserts.
** Safety narrative writing
** Assessment of causality for the non-serious AEs
** Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive work flow management
** Team SPOC for the ICSR distribution and to maintained different trackers.
** Handled Quality reviewer’s position in which performing quality check of ICSR’s processed by case processor for accuracy and completeness. Performing medical cohesiveness check in which accuracy and completeness of narrative for its medical sense is checked.
** Acting as technical trainer in which I am accountable for training the selected case processors for quality reviewer role.
** Managed the team as back up and communicate within team and outside the team.
** Managed team as a backup team lead in absence of team leader and currently acting as grooming team lead.
PROFESSTIONAL ACHIEVEMENTS AND ACCOMPLISHMENTS :
** Experience of processing more than 6000 ICSR and disposition of more than 2000 ICSR from IRT to ARISg which includes spontaneous, patient support programs (NIP), Market Research Programs (MAP) Non Interventional Study (NIS) and clinical.
** Got selected as quality reviewer based on quality of work within 1 year after joining as drug safety associate.
** Part of the Access projects, completed the projects with excellent team work before the timeline given by the client with more than 98 percent of quality and compliance. (Well appreciated by the client)
** Received best performer award from client for extra efforts towards process improvement with respect to quality.
** Got the RnR award as a star performer for the month of December 2015 and TCS Gems award for the month of October 2015 for the excellent performance (Performance linked Reward).
** Got the group recognition award (Champions League - Team) as part of the best performing team (Quality review team) in November 2015.
** Received appreciation from group lead for putting extra efforts on improvement of medical cohesiveness.
** Able to manage 100 percent regulatory compliance in ICSR processing throughout tenure
** Hands on experience of ICSR processing in ARISg safety database.
TECHNICAL SKILLS :
Excellent understanding of Pharmacovigilance and Clinical trials
Well versed with ADR assessment
(1) Causality :Naranjo’s scale and WHO scale
(2) Severity : Modified Hartwig’s severity scale
(3) Preventability : Modified Schumock and Thornton Criteria
Good knowledge of ICH-GCP, E2B and E2C guidelines
EDUCATIONAL CREDENTIALS :
** M.
Pharm (Pharmacology) Pune University 2012-2013 70.14 %
** B. Pharm Pune University 2010-2011 65.83 %
** D. Pharm MSBTE 2007-2008 76.30 %
** H.S.C Nasik Board 2005-2006 63.17 %
** S.S.C Nasik Board 2002-2003 81.20 %
PROJECTS & TRAINING :
Summer Training :
Organization : One month industrial training from 25/05/2010 to 25/06/2010 in Pioneer Pharmaceuticals Pvt Ltd., Ahmednagar.
Academic Project :
** B. Pharmacy Project on Review on “RNA interference from fundamental to therapeutic applications” in third year B. Pharm.
** M. Pharmacy project entitled “Pharmacological Evaluation of a Mushroom for it’s Anti-inflammatory and Anti-Arthritic Activity in rat models.”
COMPUTER PROFICIENCY :
Basic :Windows O/S and application software like MS-Office
Search engines :Science direct, Pubmed and Good retrieval ability of scientific data.
CERTIFICATIONS :
** Completed Basic Computer Course from Wifi Systems Computer Institute, Bharati Vidhyapeth.
** Completed Diploma in Clinical Research and Clinical Data Management from Mitcon Biopharma, Pune.
EXTRA CURRICULAR INTEREST :
** Actively participated in sports and cultural events held at graduation and post graduation level
** Participated in blood donation camp Smt Kashibai Navale college of pharmacy, Pune and TCS, Mumbai.
PERSONAL DETAILS :
Date of Birth :22nd July 1987
Marital Status : Married
Husband’s name : Mr Yogesh S Sutar
Languages known : English, Hindi, Marathi
Hobbies :Listening music, reading spiritual books
DECLARATION :
I hereby solemnly declare that all the information provided here is as per the best of my knowledge.
DATE :
PLACE :