SHAIK ANWAR PASHA.
Email : skanwarvajeer01 AT gmail.com.
PROFESSIONAL SUMMARY :
Highly creative, enthusiastic and dedicated team player with the ability to work well with minimal supervision and having 5.9 Years’ experience in Pharmacovigilance Professional. Excellent data entry skills, superior organizational, interpersonal, written and oral communication skills. Detail-oriented and focused on accuracy and efficiency. The ability to obtain a professional position, which will utilize my health care experience and skills that will provide me with an opportunity for professional and educational growth
SKILLS :
** Good knowledge about ICH and FDA Guidelines.
** Knowledge about different Regulatory Bodies.
** Medical Terminology Knowledge
** Strong Organizing skills
** Data Entry
** Quick Learner
** Excellent Communication Skills
** Excellent Attention to Detail
** Microsoft office, Excel, Internet search
WORK HISTORY :
** Pharmacovigilance-Data Analyst.
** Cognizant Technology Solutions- Mumbai, Maharashtra Sep2019-Still:
** Proficient in Quality check and case processing of serious and non-serious ADR cases concerning study cases, license partner cases, literature cases, regulatory authority cases, E2B cases and ICSR within diverse therapeutic drug classes.
** Responsible for processing Spontaneous cases, Study cases, Pregnancy cases and clinical trial cases.
** Assimilate information on adverse events, perform initial checks, update safety data tracking tool, do case validation, preliminary assessment of case reportability and create case report file.
** Ensure complete and consistent data entry of adverse event reports from source documents with acceptable timeline and quality.
** Use medical dictionaries and business guidance to check correct coding of medical history, drugs and adverse event terms.
** Identify clinically relevant information missing from case report and facilitate its collection (from medical team) to generate appropriate follow-up request as needed.
** Alert Team leader about important safety concerns based on preliminary case reports
** Work with drug safety team to ensure high compliance for end to end ICSR management.
** Handling of the CAPA sessions and providing training to new joinee.
Pharmacovigilance-Senior Research Associate Sep2018-Aug2019:
** Lambda Therapeutic Research Limited-Mumbai, Maharashtra
** Performs quality control on ICSRs and feedback of any observation to the individual who processed the ICSR. Where there are disputes, these should be escalated to the appropriate leads.
** Preparation, revision, reviews of SOPs, Wls, templates, guide and guidance training documents.
** Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements.
** Deliver training to new joinee and team as per requirement.
** Work with the ICSR team leader to escalate issues or tasks outside the normal scope of work.
** Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance.
** Performing data entry of ICSRs on the safety database and MedDRA coding.
** Quality check of labeling and listedness assessments.
Pharmacovigilance Associate Mar2015-Aug2018 :
** Tata Consultancy Services-Mumbai, Maharashtra
** Data entry of incoming Adverse Event reports and Product Technical Complaint reports onto global Pharmacovigilance safety database according to ARGUS LAM User Manual via Argus LAM intake, any other communication tool and via company label reviews from a shared site.
** Creation of an extraction form which will be the basis for the data entry in LAM.
** Extraction of relevant information from routine source documents and attachment of the extraction form as source document.
** Data Entry and Quality Check of ICSRs in Client’s Pharmacovigilance Database and other case management activities.
** Receipt and triage of case transferred via Local Affiliate Module (LAM).
** Ensuring the coding of suspect products with CDD (Corporate Drug Dictionary) and coding of concomitant medicines with WHO Drug Dictionary.
** Ensure that Serious Adverse Events are evaluated accurately and within the required timeframes to meet regulatory requirements.
** Responsible for performing daily activities in accordance to applicable Standard Operating Procedures (SOPs), Conventions & Client policies
** Wrote narratives summarizing the events according to departmental SOPs for spontaneous and literature cases through assessment of all source documents.
** Updated and entered appropriate data into Clinical database and ensured data was captured according to departmental SOPs.
** Responsible for QC of case processing and submission guidance in finalized cases from all therapeutic areas.
** Trained and mentored peers in case processing methodologies, as per regulations and local SOPs.
** Presented training session to operation team on enhanced case process workflow.
KEY SKILLS :
** Hands on experience on ARGUS safety database (version 7.0 and 8.0 & 8.1.2), Aris G and PvEdge database.
** Reviewing and processing of adverse events reported by Investigators.
EDUCATION :
** Master Of Pharmacy-Warangal 2013-2015 :
** Jayamukhi Institute Of Pharmaceutical Sciences, JNTU HYD.
** Specialization in Pharmaceutical Management And Regulatory Affairs.
Project : Registration Of Pharmaceuticals For Human In Asean Countries.
Abstract : Developing a new drug requires great amount of research in chemistry, manufacturing, controls, preclinical science and clinical trials.
Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health.
Bachelor Of Pharmacy-Kodad 2009-2013:
Teja College Of Pharmacy, JNTU HYD.
Project : Estimation Of Anti-hypertensive activity Of Captopril By Using Reveres Phase High Performance Liquid Chromatography.
Role : Team Leader.
Intermediate From Nalanda Junior College 2007-2009
SSC from Bharat Public School 2007
CERTIFICATIONS :
Participated in National Seminar Competition and Presented Poster Presentation entitled “Anti-tumor activity Of Sesamum Indicum Linn” in Anurag Pharma Quest and Won First Prize. My Abstract was Published in International Research Journal of Pharmaceutical and Applied Sciences.
ACHIEVEMENTS AND REWARDS :
Won award for excellent work in maintaining the productivity and Quality.
PERSONAL DETAILS :
Father’s Name : SK. Saleem Pasha.
Nationality : Indian.
Date of Birth : 23-Feb-1992.
Languages Known : English, Hindi and Telugu.
Hobbies : Reading books & listening music.
DECLRATION :
I hereby declare that the information furnished above is true to the best of my knowledge.
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