Mahendra Babu S

#***, *** *****, *** *****, Reddy Complex, SBI Road, Hebbal 1st stage,

Mysore-16

Mob: +919*********, email: acoszj@r.postjobfree.com

Professional Objective

To get a responsible & challenging position in PV domain in Pharmaceutical,

Healthcare, ITES and/or Clinical research organizations (CROs) & handled it

by maximum utilization of my capabilities under best technical minds.

Career Highlights

Work Experience

Organization: Synowledge PV Services India Pvt. Ltd.

Designation: Senior Drug Safety Associate

Duration: 16- Apr-2012 to till date

Responsibilities included:

As Case Intake Member:

. Receipt, tracking, acknowledging and initiation of single case drug

safety reports into the safety database.

. Maintain log of source documents and other communications

As Case Processor

. Responsible for accurate data entry, coding of adverse events and

evaluation of non-expedited and expedited (spontaneous, clinical trial

and literature) reports within well defined timeframes, in compliance

with business rules, standard operating procedures and regulatory

requirements.

. Review and evaluate AE case information to determine required action

based on and following internal policies and procedures

. Process all incoming cases in order to meet timelines

. Full Data entry including Medical coding and Safety Narrative.

As Medical Coder

. Responsible for coding all medical history, events, drugs

/procedures/indications and laboratory tests according to the

appropriate dictionary (For e.g. MedDRA, Company Product Dictionary

(CPD), WHO-DD).

As Narrative writer

. Responsible for writing medically relevant Safety narrative of cases

and checking the completeness and accuracy of the data entered in the

various fields.

As Quality Reviewer

. Evaluating and finishing processing of non-expedited and expedited

(spontaneous, clinical trial and literature) adverse event reports,

including quality review for completeness and accuracy as per partner

convention and regulatory guidelines.

. Ensuring proper coding of Event, Disease, Drug from the Respective

dictionary.

. Identifying clinically relevant information missing from case report

and facilitate its collection (in consultation with medical staff as

required) by preparing follow-up request as needed.

. Responsible for proper feedback to the Data entry associate, if

required conduct training session.

. Responsible for arrange refresher training in timely manner.

Activities Imparted:

. Interaction with client and other colleagues regarding case processing

related aspects.

. As a mentor to new hires - Trained new hires on data entry case

processing conventions.

. Associated with many Client and Internal Audits with regards to Case

processing and process adherence.

Other responsibilities included:

. Manage incoming cases in order to meet timelines [compliance

monitoring]

. Request for deletion of cases, if required

. Ensure that team follows workflow procedures, SOPs and case processing

guidelines

. Train, mentor, oversee and guide the activities of the Drug Safety and

Senior Drug Safety Associates

. Maintain high level of proficiency at all workflow tasks

. Perform any other drug safety related activities as assigned/Required

. Develop reports in Business objects.

. Work with cross-functional divisions including Customer Support,

Professional Services.

System Experience/IT Skills

. OS: Windows XP, Windows Vista, Windows7, windows8.

. Package: MS Office.

. Data Base: ARISg 5.1, ARISg7, Argus.

Professional Qualification

MSc. Clinical Research in 2011 from Institute of Clinical Research

India affiliated to Cranfield University (UK).

Academic Details

COURSE COLLEGE/INSTITUTION UNIVERSITY YEAR

B.Pharmacy CNK Reddy college of pharmacy RGUHS (Karnataka) 2009

Intermediate Ratnam college, Nellore IPE board (Andhra 2005

Pradesh)

10th Sri Vignana Jyothi High School, SSC board (Andhra 2003

Punganur Pradesh)

Recognitions and Awards

. Received award as a best case processor of the month for extraordinary

work on prioritization of cases, triage, and case processing and

project deliverables.

. Awarded as Best outstanding Performer for quarter.

Conference Attended

. Attended International Conference on Pharmacovigilance and Clinical

research: Regulatory and Ethical concerns around the globe held on

February 26, 2011 at Goa.

Personal Summary:

. Quick learning skills with a positive outlook

. Leadership Quality

. Action Oriented deliverables.

. Good Oral and Written communications

Personal Details:

Fathers Name : Mr. S Venkata Swamy

Date of Birth : 08/06/1987

Nationality : Indian

Gender : Male

Marital Status : Married

Languages Known : English, Hindi, Telugu and Kannada

Permanent address : #23-56/1-1, High school street,

Punganur-517247, Chittoor [Dt],

Andhra

Pradesh.

I hereby declare that all the information mentioned above is true to the

best of my Knowledge and belief.

Mahendra Babu.

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