NAYEEMULLAH KHAN MOHAMMED (IMMEDIATE JOINER)
To secure a challenging position in the organization and to excel as a Successful Employee and to strive for the growth of it by becoming the part of the team with hard work and commitment.
Senior Process Associate: Dec/2015 –Mar/2016
Worked as a Senior Executive in Pharmacovigilance (Drug Safety) at iMED Global Corporation, for Client Johnson (USA).
Provide solid core and some comprehensive medical coding expertise to provide efficient, quality data coding products that meet customer needs.
Role and Responsibilities:
Create medical coding plan and perform coding of medical data.
Perform manual coding for which auto coding is not successful
Generate queries to safety teams for non-coding clarification of terms (e.g., to clarify illegible text, etc) and close the queries
Ensure the coding dictionaries are maintained as per the agreed versions.
Understand and implement the process by which medications and adverse events are classified.
Understanding of the roles and technology involved in classification, and to provide useful tools that aid the editor in obtaining preferred terms for every reported medication and adverse event.
Maintain rules for updating or referring medication or adverse event verbatim.
Generates and maintains all required documentation, including the development of coding specifications.
Administration and maintenance of the adverse events and drug Dictionaries.
Evaluation for accuracy of coding and re-coding of adverse events and other safety data (medical history, disease state and indicators) using MedDRA terminology as well as methods to convert other medical terminologies to MedDRA,
Other bridging techniques including MedDRA versioning upgrades.
Understand and comply with core operating procedures and working instructions.
Develop and maintain good communications and working relationships with cross functional team.
Senior Process Associate: Jun/2014 –Dec/2015
Worked as a senior process Associate for Tata Consultancy services, Pune.
To deliver offshore Pharmacovigilance services to Client (Amgen Pharmaceuticals) in a timely and reliable fashion.
Evaluates the consistency, completeness, accuracy of safety database, tracking database, and source document entry forms.
Data entry from the source documents either structured or unstructured source documents by identifying the suspect drugs, concomitant drugs, seriousness criteria of the event, medical history, and past events.
Be responsible in meeting timelines, and quality standards.
Provides accurate, complete, and consistent data in compliance to the guidelines in the protocol that could be submitted to various Regulatory authorities.
Role and Responsibilities:
Be fully competent to perform all steps within the case-handling process from data entry to distribution.
Contribute to the development and implementation of new safety-related systems, processes, and procedures within the process.
Support a performance-driven culture.
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes, and procedures.
Provide scientific and technical contribution to the maintenance of one or more of the Support Section activities within the process.
Safety narrative writing of Clinical Trial, Serious and Non-serious spontaneous and solicited reports.
Junior safety Data Analyst:
Sciformix Technogies Pvt Ltd, Pune. April 2013 – Jun 2014
Case intake, performing duplicate check.
Data entry of individual case safety database including medical coding and safety narrative.
Coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary.
As Literature Review Specialist
Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
Review of literature articles to identify case safety reports.
Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
Ensure quality of literature searches and reporting.
Synowledge PV services, Mysore. April Jul – Dec 2012
DOMAIN SKILLS :
Pharmacovigilance : Argus Safety 7.0 and 5.1.
Arisg: V5.0 and 6.0.
MedDRA V 19.0
Rave and Medidata Rave.
WHO Drug dictionary
Master of Pharmacy JSS college of Pharmacy, Mysore 2012.
Bachelor of Pharmacy JNTUH, Hyderabad 2010.
Narayana Junior college, Hyderabad in 2006
Sujatha High school, Hyderabad in 2004
Principles of Clinical Pharmacology (National institute of Heath USA) 2012
Introduction to Principles and Practice of Clinical Research (National institute of Heath USA) 2012
Registered as a pharmacist under the Andhra Pradesh Pharmacy Council (India).
Registered as a pharmacist under the Dubai Health Authority (Dubai).
Registered as a pharmacist under the Saudi Commission of Health Specialties.
Office Tools : MS Word, Excel, Power Point
Operating System : Windows98, xp,windows7, 8, and 8.1
Awarded with roll of honor in monthly Rewards & Recognition award.
Awarded with clap card in monthly Rewards & Recognition award.
Highly motivated, dynamic, proactive, disciplined, confident, and goal oriented.
A self-directed professional with excellent clinical, communication, interpersonal, and problem solving skills.
Able to work independently in safety related duties manage and mentor other employees.
Can process huge number of cases with 100% accuracy as the primary objective.
Summary of Experience:
A Pharmacy post-graduate by education, worked as a senior executive at iMED Global Corporation.
Received special training in Pharmacoviglance including data entry, triaging and complete case processing.
Good knowledge about drug dictionaries including MedDRA, WHO DD and coding.
Good knowledge of Regulatory guidelines of various countries including reporting time frames.
Date of Birth : 21st March 1987
Father Name : Mohd. Ziaullah Khan
Mother name : Tahera Begum
Address for Correspondence: 2046 W Devon Ave unit 1, Chicago, Ilinois, United States
Sex : Male
Nationality : Indian
Languages Known : English, Hindi and Urdu.
I do hereby declare that the particulars of information and facts stated herein above are true, correct and complete to the best of my knowledge and belief.