Drug safety Associate

Riaz Ahemad **********@*****.***

B*,***,**th street,Brooklyn, NY 11219 Mob# 224-***-****

Academic Credential

Long Island University, Brooklyn, New York Aug 2014 May-12 2016

Master of Science in Pharmacology, GPA 3.81

Sumandeep Vidyapeeth University, India July 2009-June 2011

MBA HealthCare Management, GPA 3.25

SJ College of Pharmacy, India

Bachelor of Pharmacy, GPA 3.92,

CERTIFICATION; Registered Pharmacist

Pharmacy Council of India, India

Drug Safety Associate

Cipla Ltd, India Jul 2011 – July 2014

Supporting Clinical and Post-Marketing Safety Experts in processing Adverse Event reports from all sources including clinical trials, post-marketing and published literature reports into the global Safety databases.

Responsible for data entry and coding of Clinical Trials (Not Related), Solicited, Post Marketing and Literature

both Initial/Follow-up cases into ARISg in line with ARISg user manual.

Coding AEs and other medical terms into standard dictionaries (MedDRA, WHO Drug).

Writing drug safety narratives according to approved templates by extracting the template for appropriate protocols, and based on information provided on standard AE forms, from Medical Records and other documents.

Ranking the event terms.

Creating Rechallenge/Dechallenge Writing case summary and distribution comments.

Responsible for verifying the accuracy and completeness of information for each adverse event report in conjunction with the source documents.

Performed quality review of individual case safety reports and for providing feedback to team members, working closely with the Case Processing team

Contributing in trainings to the new hires by reviewing and proofing their work, providing feedback and comments.

Ensuring the activities are performed in a manner consistent with Pharmacovigilance Standard Operating Procedures (SOP).

Drug Safety Associate

Dr Reddys Ltd, India

Sep 2006 – Jun 2009

Performed overall processing of adverse event (AE) information in compliance with applicable FDA and global regulations and Company’s Standard Operating Procedures (SOPs) and guidelines

Performed duplicate case check, triaging and data entry of individual case safety reports into the safety database

Review and evaluate AE case information to determine required action based on and following internal policies and procedures.

Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary ( MedDRA, Company Product Guide, WHO-DD)

Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields

Performed Case assessment and determined causality, relatedness of the AE case information.

Participated in assessing whether a case should be downgraded to upgraded in seriousness after initial and follow-up information

Created queries for Adverse Events report clarification

Ensured effective and accurate collection, recording, review and reporting of literature searches conducted.

Inform Sr. Manager regarding the safety related issues, potential trends or signals arising from review of pre and post marketed safety data

Identified and followed department Standard Operating Procedures (SOP) for Serious Adverse Events (SAEs), and Adverse Event (AEs) associated with product complaints

Certification & Publication:-

oAward & Recognition:-Rho Chi; National Academic Honor Society in Pharmacy, Brooklyn, NY

Registered Pharmacist, Pharmacy Council of India.

oPublication:-An Analytical Study of Influence of Advertisement on Social Networking Sites on Buying Behavior of Selected Students of Baroda City, Gujarat, India. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.684.8475&rep=rep1&type=pdf

Riaz Ahemad

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