Safety Management

HEER BHATT

**** ******** ****, *** #***, Cincinnati, OH 45245

aczhm0@r.postjobfree.com • 331-***-****

Pharmacovigilance Scientist/ Drug Safety Associate with 2.5 years of experience in triaging, assessment, and processing in Aris G database software and agXchange.

Core Competencies:

Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.

Knowledge of 21 CFR Parts 11/314/20, Volume 9 A, MHRA best practices, CIOMS guidelines and ICH recommendations.

Extensive knowledge of drug safety and drug development process and procedures.

In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines.

Knowledge of Periodic Safety Update Reports (PSURs).

Possess sound communication skills, both in verbal, and written.

Professional Experience:

TATA CONSULTANCY SERVICES (TCS)

Roche /Genentech – Cincinnati, OH Mar 2016– Present

Pharmacovigilance Scientist 1

Review source documents for accuracy of triage assessment to include case priority, awareness date, internal and external completion/submission dates.

Follow case processing management of Clinical Case Reports and Spontaneous Individual Case Safety Reports.

Processing of Pregnancy cases, Day 7 and Day 15 timeline SUSAR ICSR along with Licensee time line ICSR.

Responsible for providing root-cause analysis (RCA) for findings in ICSR. Proactive communication to management with issues and suggested solutions for process improvement.

Drafted individual case summary reports and wrote concise case specific narratives as per company/product conventions.

Accountable for performing the appropriate clinical assessments (including the assessment of seriousness, labelling and company causality for each adverse event).

Required information queried and interacted to responsible representatives untill all follow up information is obtained and queries are satisfactorily resolved.

Hands on experience in MedDRA and knowledge of ICD coding & various Thesaurus Management Systems.

TATA CONSULTANCY SERVICES (TCS)

Roche /Genentech –Mumbai, India

Pharmacovigilance scientist I October 2014 –Jan 2016

Triaging of cases.

Accountable for handling ICSRs received via data exchange systems, disposition of valid items into ARIS from IRT for further processing in ARIS.

Acknowledging receipt of ICSRs to sender within the timelines documented in the relevant SOP.

Handling invalid items in IRT appropriately through reference to SOPs, relevant training and the ARIS user manual.

Processed Clinical cases, Non Interventional Study Cases, Market Research Program Cases, SDEA (Safety database exchange agreement) cases, Spontaneous cases and special situation cases.

Ensured accuracy of coding and performed mergers.

Performed effectively on assigned cases.

Created workflow trackers, flow charts, power point slide presentations as needed.

Technical Skills & Expertise

ArisG Safety Database, agXchange

Proficient knowledge of MS office

Technical internship in tablets, capsules, oral-liquid from Bombay Tablet Mfg. Co. (PVT) Ltd. from April 2011 to June 2011.

Education:

Masters of Pharmacy (Pharmaceutics)

Rajiv Gandhi University of Health Science, Bangalore, Karnataka.

Thesis:

“Study of formulation variables of Promethazine Hydrochloride Lozenges”. Prepared medicated lozenges with a phenothiazine derivative for Motion-Sickness.

The effect of different polymers were checked in in-vitro release of the drug.

Symposiums attended:

National seminar on recent trends in Traditional drug research and validation, 2012.

National seminar on Research methodology and research grants, 2012.

62nd Indian Pharmaceutical Congress (IPC) Conference held in Manipal, 2010.

National Seminar on Industry– institutional approach towards pharmaceutical technology, 2009.

Personal Profile:

Date of Birth: Jul 5th 1989.

Languages Known: English, Hindi and Gujarati.

The above information is true to the best of my knowledge.

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