Brijesh Shah

*** ********* *****, ********, ** **446, 516-***-****, ac4h1l@r.postjobfree.com

EDUCATION

Temple University, School of Pharmacy Philadelphia, PA Masters of Science in Regulatory Affairs and Quality Assurance Nov’17 Temple University Certificate Program Philadelphia PA Drug Development Certificate Jun’17

Rajiv Gandhi University of Health Science Belgaum KA Bachelors of Pharmacy Jun‘14

RELEVANT COURSEWORK SKILLS

Drug Development

IND-NDA

Pharmacovigilance

cGMP/GCP

Food and Drug Law

Global CMC Issues and Regulatory Dossier

Post Marketing Safety Surveillance

Global Biopharmaceutical Industry

Quality Audit

Regulatory Intelligence

Design Control of Medical Device and

Combination Products

Risk Management of Pharmaceutical and

Medical Device

RELEVANT PROJECTS

Prepared broad path of registration for drugs in accordance with FDA guidance for successful approval of the application

Prepared draft agenda and protocol for a pre-IND-NDA meeting submission

Participated in in-class pre-IND/NDA meeting to better understand how to discuss and negotiate with FDA regarding protocol, inclusion and exclusion criteria and submission

Performed and presented case study on withdrawal of various drugs to better understand the role of Pharmacovigilance and implementation of REMS in FDAA Act 2007 to safeguard human health

Performed small unit dosage formulation in compliance with cGMP, prepared and submitted batch record to show the better understanding of cGMP requirement

Prepared and submitted audit plan, agenda, and checklist for CFR-210, 211, 312- cGMP/GCP compliance inspection

Prepared and submitted complete portfolio of design control for medical devices compliant to QSR CFR-820, ISO-13485

Performed risk management plan for medical device and pharmaceutical using various risk management tools such as FMEA, FTA

Carried out scoping literature review on Global Biopharmaceutical Industry

Reviewed article on single payer system

WORK EXPERIENCE

Technical Assistant, Temple University, PA Sept’16-Nov’16 Medical Representative, Zydus Cadila Pharmaceutical Feb’15 - Dec’15

Promoted Zydus drugs to physicians as per company’s regulation to improve business and sales

Discussed mechanism of action, medical use, contraindications, safety and adverse events related to drugs for better understanding and benefit of prescriber and patients

Actively participated in supporting audit sales report and pharmacovigilance plan of a company to identify the adverse drug reaction to provide safe and effective drugs to patients

Encouraged prescriber and patients to submit adverse events and quality issues experienced with drugs to determine new safety concerns that might be related to prescribed drugs

Conducted training session for new Medical Representatives on pharmacology of drugs which gives them strong scientific background to better promote the drugs to the physicians

Prepared and analyzed activity reports of medical science liaison, weekly work plans, monthly and quarterly territory performance to update the management

Identified and segmented potential physicians for launch of new or available combination product and fixed-dose combination products which successfully improve business volume

Established new client/accounts and catered to existing ones

Monitored competition by gathering current marketplace information on pricing, products, new products, delivery schedules

Used regulatory intelligence to understand the current regulation and market scenario to provide real-time information to corporate sales

Research and Lab Technical Assistant, Dr. V.K (Pharmacy college) Sept’12-May’14

Provided research support in determining the uterus contraction activity using herbal drug on female rat (Oxytocic activity of cumin extract)

Assisted in Laboratory activities;

Prepared and stored physiological salt solution for experiment and arranged instrument set up like organ bath and other relevant instruments

Performed and examined the pharmacological activities of Acetylcholine, Histamine, Adrenaline on laboratory animals

Performed and measured dose and potency determine analgesic activity of various analgesic drugs on lab animals using various analgesiometer

Extraction of chemical constituents using principles of pharmacognosy to isolate and effectively measure the drug response in lab animal

Prepared various formulation of drugs, conducted quality test and analyzed trace impurities to improve formulation purity and strength

Performed Analytical experiments using a chromatographic technique for separation and identification of amino acids, proteins etc.

Performed drug stability testing such as dissolution, disintegration, content uniformity, hardness, and friability test, sterility test (for parenteral) to assure drug quality and stability Intern, Phyto Concentrate Jul’14 – Jan’15

Successfully completed training as an intern for end to end processing in GMP lab.

(manufacturing, testing, packaging and labeling) of drugs at Phyto Concentrates Pharma WORKSHOP AND TRAINING Nov’16

Attended a workshop on Good Manufacturing Practice and also on requirement and compliance of cGMP, at Almac Pharmaceuticals, Souderton PA.

Computer Skills:

Microsoft XP applications (Word, Excel, Office, PowerPoint, Outlook, Access)

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