RAMESHBABU PROFILE LATEST(1) (1)
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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.
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Adel G. Said is seeking a position as a drug safety and pharmacovigilance associate. He has over 7 years of experience in the pharmaceutical industry, including roles in pharmacovigilance and drug safety at Servier Pharmaceuticals in Egypt. He has a Bachelor's degree in Pharmaceutical Sciences from Alexandria University in Egypt and is currently interning at Rite Aid pharmacy in Princeton, NJ. His experience includes adverse event reporting, drug coding, clinical trial monitoring, and ensuring safety guidelines are followed.NEW PRIYANKA CV
NEW PRIYANKA CVpriyanka patel
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Priyanka Patel is applying for a position in pharmacovigilance. She has over 7 years of experience in pharmacovigilance and quality assurance. Currently, she works as a Junior Data Analyst/Medical Safety Specialist at Cognizant Technologies Solutions, where she performs case processing, quality checking, medical coding, and ensures regulatory reporting requirements are met. Previously, she worked as a Pharmacovigilance Scientist at Tata Consultancy Services and in quality assurance at Pfizer Production Plant. She has expertise in Good Clinical Practice and skills in communication, problem solving, and training.CV Bhavik Patel-
CV Bhavik Patel- Bhavik Patel
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Mr. Bhavik Patel is seeking a position that provides challenging work and opportunities for growth. He has a Master's degree in Pharmacy and over 4 years of experience in quality assurance roles. His experience includes preparation of SOPs, change control, deviation handling, risk assessment, vendor qualification, and audit management. He is proficient in MS Office, SAP, and has strong communication, problem-solving, and leadership skills.ROSHAN CV (2) (1) (1)
ROSHAN CV (2) (1) (1)ROSHANKUMAR shetty
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Roshan Kumar S is a Clinical Process Associate-2 with 1.8 years of experience in clinical research. He has thorough knowledge of clinical trials, ICH-GCP guidelines, and medical terminology. His roles include performing administrative tasks, assisting with data management, establishing communications, and ensuring documentation quality. He also monitors studies and communicates with clients, and has skills in computer programs, analytics, communication, and time management.SRIVIDHYA.doc
SRIVIDHYA.docDr.Srividhya .
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This resume is for Srividhya, who has over 10 years of experience in drug safety and pharmacovigilance. She currently works as a Serious Case Processing Quality Control Officer at Accenture Pharmaceutical Services in Bangalore. Prior to this role, she held positions as a Drug Safety Scientist and Senior Drug Safety Associate at Accenture. Srividhya has a Bachelor's degree in Dental Surgery and a post-graduate diploma in Clinical Research and Clinical Data Management. She is proficient in databases such as Argus and Empirica Trace and has experience with medical coding, case processing, quality assurance, and regulatory compliance.Hitesh maheshbhai patel
Hitesh maheshbhai patelhitesh patel
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working in Quality assurance department in Qualification and validation department.
involve in new equipment qualification like multi connected tank ( Skid).
involve in media fill activity and investigation.
involve in qualification of HVAC.
involve in new facility startup activity.Ad
RAMESHBABU PROFILE LATEST(1) (1)
- 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 MAR22, 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油Employment油History:油 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速 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.