Drug Safety Coordinator

Dr. KUNAL MESHRAM Phone No. : 408-***-**** Email: *********@*****.***

OBJECTIVE: To obtain a position that will further develop my skills in Drug Safety Field to contribute to the growth of the company at global level.

SUMMARY:

Around 1+ yr experience in Drug Safety and 2+ yr experience in Health Care Sector.

Comprehensive knowledge of Clinical trials (Phase I – IV).

Extensive experience working with clinical Safety data and databases.

Acquired knowledge of regulatory and good clinical practices (GCP) and international conference of harmonization (ICH).

Experienced with WHO-drug, WHO Art and MedDRA coding.

Knowledge of study activities, coding, review and clarification activities.

Ability to handle multiple projects with rapidly changing priorities and deadlines.

Dependable, Detail oriented, self- motivated professional with ability to work individually as well in a team environment.

Strong written and oral communication skills.

PROFESSIONAL EXPERIENCE:

Unijules Life Sciences Ltd, India. 09/2009- 11/2010 Drug Safety Associate

Hands on experience on ARISg and ARGUS databases.

Assisted in tracking information regarding potential adverse events submitted by all reporters including consumers, healthcare professionals, co-manufacturers, Call Centers, Medical Information, Quality Assurance and other Company representatives accurately within defined reporting timelines.

`Reviewed the quality of data produced by other Drug Safety Associates for all serious adverse event reports prior to completion through the safety database workflow.

Reviewed and processed initial and follow-up information for both serious and non serious adverse events in safety database by producing a narrative using the appropriate narrative template and coding adverse events, suspect products and concomitant products using MedDRA and other company dictionaries within defined reporting timelines.

Processed and assigned cases in the validated database (ARISg, ARGUS) by performing assigned roles (data entry, safety processing, and safety reporting) within Global and local timeliness.

Reviewed the appropriate selection of adverse events from source documents, appropriate MedDRA code and seriousness for each adverse event and accuracy of label assessments for each adverse event.

Completed the tasks resulting from departmental interfaces, e.g. with data management (listing review, SAE reconciliation), medical writing (narrative review).

Started preparing Adverse Event Reporting Plans (AERPs), Reconciliation Plans, and other safety-specific plans ensuring optimal efficiency.

When needed worked with Data Management or client on reconciliation of safety databases.

(01/2009-06/2009) at SDKSD College & Hospital, India.

Job Title: Lecturer - Department of Endodontics

(07/2008-12/2008) at SDKSD College Hospital, India.

Job Title: Clinical Assistant

(10/2007-06/2008) at Dr. Gade’s Multispecialty Clinic, India.

Job Title: Clinical Assistant

EDUCATION AND PROFESSIONAL CERTIFICATION:

Bachelors of Dental Medicine & Surgery, India

MBA in Bio-Management, USA.

COMPUTER SKILLS:

Windows XP, MS Office Tools – MS Word, Excel, Access, PowerPoint.

Dr. KUNAL MESHRAM

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