Soumya Balachandran

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Professional Profile

Senior Drug Safety SME with greater than 4 years of consistently successful work experience in the field of Pharmacovigilance and drug safety. Proficient in handling PV databases like ARGUS and ARISg with diversified skill sets covering client relations and administrative support. Mentored and trained 250+ Drug Safety professionals for multiple Pharmaceutical companies, providing services in countries like Germany, Philippines and India.

Related Skills and Experience

ICSRs, PSURs/PBRERs, PADERs

Handled end to end PV activities from

• Aggregate reporting

• Case registration/booking

• Case Triage

• Case processing which includes Data

entry of ICSR’s

• AE/ SAE and product coding

using Med DRA and WHO-DD

• Event labelling with the use of

IB, CCDS, SmPC and PI

• Clinical Trial unblinding: End of

study and SUSARs

• SAE reconciliation

Certified as “Global Pharmacovigilance

Trainer” by 2 Pharma organizations

In-house Pharmacovigilance expert for

Cognizant at new business transitions

Knowledge on ICH-GCP, FDA and EMA

regulations.

Developed training calendar, plan and

organize training programs.

Trained Pharmacist

Assist in Root cause analysis, CAPA

Knowledge of RMP/ REMS, signal detection

GCP and CITI certified

Basic understanding of CDISC standards for

SDTM and ADaM

Novice SAS programmer

Soumya Balachandran, MS, BS Pharmacy

acuysf@r.postjobfree.com

734-***-****

Soumya Balachandran

acuysf@r.postjobfree.com

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Curriculum Vitae

Professional Experience:

Cognizant Technology Solutions India and Philippines Mar 2013-Dec 2014 On assignment for Boehringer-Ingelheim as Offshore lead/ Mentor

Handled end-to-end Pharmacovigilance activities with a team of 250+ drug safety associates working across different geographical locations between Mumbai, India and Manila, Philippines.

Trained 6+ batches with 25+ associates in individual batch.

Mentored 250+ associates in a span of 1.5 years on case processing parameters like narrative writing, labeling, causality assessment, seriousness criteria, coding of drugs and adverse events through Med DRA and company dictionaries for reports origination from different sources like clinical trial, spontaneous, compassionate, patient registries, health authority, license partners as well as litigation cases.

Played a key role in successful transition of the project in Mumbai, India with a dual delivery center at Manila, Philippines.

Responsible for updating the team on changes in FDA, EMA regulations and guidelines with respect to the time line in submitting reports.

Actively involved in preparing and updating training material with reference to SOPs and product Guides. Refresher trainings conducted to update the team regarding the modifications.

Responsible for completion of full case information on the database, ending in Quality Review to ensure accuracy and completeness

Responsible for reviewing individual training files of 250+ associates before the audit and notify the team about corrections.

Responsible for archiving and documenting data.

Actively involved in prioritization and allocation of work to drug safety associates to meet regulatory submission timelines.

Responsible for generating Periodic Safety Update Reports (PSURs)/PBRER(Periodic Benefit Risk Evaluation Report) and Periodic Adverse Drug Experience Reports (PADERs) for submission to world-wide regulatory agencies.

Assessed and reviewed all serious adverse events (SAEs) cases, adverse event reports from all sources (clinical trials and spontaneous).

Assisted in developing and revising local processes, procedures, and SOPs pertaining to safety issues.

Experience in writing many sections of aggregate reporting.

Reviewed cumulative information from wide sources periodically, especially focusing on new updates on PSUR/PBRER and PADERS.

Evaluate and finish processing of non-expeditable AE reports, including review for completeness and accuracy.

Soumya Balachandran

acuysf@r.postjobfree.com

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Boehringer-Ingelheim Germany Dec 2012-Mar 2013

As Drug Safety SME/ Trainer

Represented Cognizant as a pharmacovigilance expert at Germany for a business transition.

Certified as “Global Pharmacovigilance Trainer” by the client based on excellent domain knowledge and delivery skills.

Part of the pivotal Boehringer-Ingelheim pilot project. Cognizant Technology Solutions Mumbai, India Dec 2011-Dec 2012 On Assignment for Novartis as Offshore Mentor

Trained 5+ batches with batch size of 25 + drug safety associates in a span of 1 year to perform pharmacovigilance activities.

Mentored 125+ associates for the case quality.

Reviewed 200+ training files of individual associates in the clinical Trial team with corrections and re-reviewed as and when required.

Quality report submission to the leads and manager.

Main point of contact for query resolution and trained professionals in leadership positions like Team Leads.

Novartis India Sep 2010 – Dec 2011

As Safety Processing Expert

Case receipt and triage of incoming cases to determine seriousness for prioritization of daily work flow.

Responsible for reviewing of the adverse event completeness, accuracy and documentation in compliance with standard operating procedures (SOPs)/ working practice document

(WPD) and drug regulatory requirements.

Performed case processing of serious and non-serious cases with clear, concise and comprehensive case narratives procured from relevant, related information from various source documents. Used MedDRA and WHO-DD for coding.

Performed labelling of an event using labelling documents like Investigator Brochure (IB), Company core data sheet (CCDS), Summary of product characteristics (SmPC) and Patient information leaflet.

Responsible for end of study unblinding, SUSAR or single unblinding and critical case correction.

Responsible for QC of higher risk cases and interface with investigator sites to ensure complete and accurate event reporting.

Performed thorough data reconciliation and requested follow-ups as per the regulatory requirements.

Overall responsible for processing ICSR’s starting from Initial review, safety database entry, tracking, Serious Adverse Events (SAE) coding, narrative writing, requesting follow-up from the clinical site for pending areas.

Soumya Balachandran

acuysf@r.postjobfree.com

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Processed cases from various sources like literature, spontaneous, post marketing surveillance and Clinical Trials giving special importance to License partner and health authority reports.

Part of all the therapeutic areas with specialization in cardiovascular, oncology and transplantation products.

Mentored 10+ associates for quality of cases.

Trained 2 batches for Clinical trial data entry. Education

Masters of Science, Clinical Research Jan 2015 - Apr 2016 Bachelor of Science, Pharmaceutical Sciences Jun 2005 - Jun 2009

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