Kota Ramesh Babu is seeking a position in pharmacovigilance with over 3 years of experience in case processing, coding, and narrative writing. He is proficient in MedDRA coding and databases like Oracle Argus. Currently working as an Associate Operational Specialist at Quintiles, his previous role was a Drug Safety Associate at HYSYNTH Biotechnologies where he participated in audits, reviewed cases, and ensured regulatory compliance. He has a Master's degree in Pharmacy and a certificate in pharmacovigilance. Ramesh Babu is a motivated team player focused on quality and meeting deadlines.

1. Kota Ramesh Babu
Email:
kotampharmacy@gmail.com
Phone No: +91 9916767474
OBJECTIVE:
An opportunity to work in a vibrant and exciting environment that values my skills to
improve positively towards the growth and prosperity of the company and also to secure a
position in this ever-expanding field by virtue of my sincerity and dedication.
SYNOPSIS:
• A result oriented professional around with 3.04 years of experience in
Pharmacovigilance.
• Presently working with Quintiles from 19-JAN-2015 to present as Associate operational
specialist and previously worked with HYSYNTH Biotechnologies {Since MAR’22, 2013},
Chennai as Drug Safety Associate for EU Process.
• MedDRA coding proficiency.
• ORACLE ARGUS 7.0 and SCEPTRE Expertise.
• Complete knowledge of Overall Pharmacovigilance Practices for both USA and EU
Processes including Case validation, case Processing with other Pharmacovigilance
related work.
NARRATIVE WRITTING:
• Drafting and review narratives for the data and creating high standard scientific
electronic documents especially for psychotic products and biological products.
AREAS OF EXPERTISE:
Quintiles Employment History:
• Initial receipt, Database searches as necessary. Registry and Triage of incoming cases to
determine seriousness for prioritization of daily workflow.
• Completion of literature searches as necessary.
• Completion of case processing (Case data entry, labeling, approval numbers, manual
Coding, Narrative writing) and Quality review.
• Clarification of unclear or illegible information from Local Safety Officer or Call Centre
and customer communication as per project requirement.
• Discuss source documents, coding conventions and ad-hoc queries with
pharmacovigilance physician.
• Completion of protocol request forms as necessary.
• Request deletions/ Admin edit requests as necessary.
• Legal case processing including triage to reporting.
• Other Case processing related activities. (E.g. consistency checks etc.).

2. Hysynth Job profile:
• The scope and scale of activities with which this job is concerned and is involved as Drug
Safety Associate.
• Manage daily workload in conjunction with PV Manager/team lead for individual case
processing and any other tasks relevant to the Pharmacovigilance Department.
• Data Entry and Quality Check of ICSRs in pharmacovigilance database (ORACLE ARGUS
6.0) and other case management activities.
• Compliance with the Company Standard Operating Procedures and regulatory
requirements.
• Liaise effectively and maintain excellent relationship with the managements and
collogues.
• Maintain awareness of changes to new regulations affecting Pharmacovigilance
activities.
• To carry out necessary administrative duties required for the job.
• To contact, as required, UK / US office(s) and customers/clients in order to achieve
required outcomes and meet timelines
• Liaise with other Pharmacovigilance executives and Pharmacovigilance Officer to
manage individual case processing timelines and quality check as necessary.
• Follow-up of serious and non-serious cases.
The scope and scale of activities involved as DSA:
• Actively participated in audit of Pharmacovigilance system in Dec 2013 and Sep 2014
and was able to complete without any critical findings.
• Review and verify appropriate selection of adverse events from source documents,
appropriate MedDRA (Medical Dictionary for Regulatory Activities) code for each
adverse event and accuracy of product label assessments for each adverse event.
• Review the source document to assure relevant information pertaining to the case is
appropriately entered into the database fields.
• Handled Spontaneous cases, pregnancy cases, overdose cases Prepared ADRs forms and
closed the case satisfactorily.
• Co-ordinated in development of SOPs and working guidelines for maintaining quality
standards in the work and to comply with regulations. Responsible to perform Case
Processing as per related SOPs, Work Documents, Sponsor reference documents, etc.,
• To provide consultation on data processing related queries received from
Pharmacovigilance and the same shall be tracked and documented for audit purpose.
• Ensure quality, productivity and timeliness of work.
• Possess/acquire exceptional operational knowledge on PV software i.e. Oracle Argus®
and be prepared to learn any client-specific PV database/software.
• Be proactive to follow/adhere “First-time OK” principles in delivering quality reports.
• Active in pursuing project-related tasks/functions and deliver assignments on time, as
assigned by Team Lead.

3. TRAININGS ATTENDED:
• Training on MedDRA
• Training on Leadership skills and effective communication
• Training on “Managing Self and Others”
• Guidelines on adverse reactions and CFR & ICH regulations
• Training ORACLE ARGUS 7.0.
ACADEMIA
• Master of Pharmacy-Pharmaceutics from Samskruthi college of Pharmacy (2013), Hyd,
A.P with 75%.
• Certificate in Pharmacovigilance, Clinical data management& Clinical research from
Syncorp, Bangalore.
PERSONAL ATTRIBUTES:
• A highly motivated, hardworking and dependable person. Punctual, reliable and willing
to learn.
• Able to work both independently and in a team with a good eye for detail. Able to
organize and integrate individual efforts into a team.
• A team player with a flair for motivating collogues. Work to ensure that internal and
external timelines are met.
PERMANENT ADDRESS :
• Address : S/O SATHYANARAYANA,H.NO-5-69 ,
CHVR Street, Ayyagaripet, sathupally,
Khammam (DIST), Telangana.
DECLARATION:
I hereby declare that the information furnished above is true to the best of my Knowledge.
Place:
Date: Rameshbabu.