Megha Shah R.PH.

Colmar, PA

Cell:215-***-**** adg4cy@r.postjobfree.com LinkedIn URL

PROFESSIONAL SUMMARY

Experienced healthcare professional with 13 years’ experience in patient care and clinical research, focused on adverse event reporting of investigational and post-marketed drugs. Trained in pharmacovigilance and working with global safety database.

SKILLS

Experience using Oracle Argus Safety 8.1 to receive, triage, process, complete data entry, and follow-up on AEs/SAEs reports from various sources including spontaneous, regulatory authority, literature and clinical trial case reports

High level of understanding of applicable regulations, including FDA (21CFR 312 and 314), ICH (E2A, E2B, E2C), GCP guidelines, EMA regulations, and GVP Modules

Proficiency in writing concise medical narratives and preparing MedWatch and CIOMS forms. Proficiency in using IME list, MedDRA and WHO drug dictionary to correctly code adverse event

Basic knowledge in Pre-and Post-marketing clinical trials, Pharmacovigilance, Aggregate reports, ICSRs, DSURs, PSURs, PBRERs in compliance with Regulatory authorities

Excellent written and verbal communication skills

Ability to work effectively and collaboratively in a fast-paced team environment and with individuals at all levels. Effectively multi-task and ability to prioritize work

Manage and mentor team to surpass Pharmacy business goals.

Computer & Database Skills

Microsoft Office Suite (Word, Excel, Outlook, Access, Power Point), Oracle Argus 8.1, MedDRA, WHODD, RX2001, Nextgen, Connexus, and Framework.

WORK EXPERIENCE

Drug Safety Intern, Sollers College, NJ Apr 2020 - Present

Evaluate the source document for completeness and extract relevant information

Process SUSAR cases from various sources such as clinical trial, post-marketed, literature, solicited, non-serious, and serious adverse event cases

Perform duplicate case search and accurately capture patient, product, reporter and event data in Oracle Argus safety 8.1

Triage and code medical history, laboratory and other investigational test results, adverse event terms using MedDRA 23.0 and WHO drug dictionary

Write accurate and detailed clinical case narratives ensuring that all the relevant information is present in the chronological order of occurrence

Accurately capture listedness/expectedness of adverse events researching USPI, PubMed, Daily med and company core data sheet

Generate queries using ARGUS interface for clarification, resolving and forwarding to next workflow

Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow-up requests

Trained in contributing towards Aggregate Reports, PSUR, PBRER and PADERs

Triage SAEs, evaluate and enter SAE data for completeness, and regulatory reportability

CVS Pharmacy, Dresher, PA Oct 2018-Present

Staff Pharmacist

Dispense, fill, and verify prescription orders and handle issues regarding drug utilization reviews (DUR), third parties, and prescriptions

Provide immunization and best customer services to patients.

Maintain, train and coach pharmacy support staff for filling and dispensing of medications and proper customer service, safety and inventory control

Partners Pharmacy, PA Feb 2018- Oct 2018

Clinical Pharmacist

Processed, prepared and dispensed legend, controlled c2-5 and intravenous prescriptions through the close door pharmacy Framework system including claims to third party insurance plans

Prepared sterile solutions, intravenous medications and infusion for use in facilities, nursing homes, assisted living facilities

Rite Aid Pharmacy, PA Feb 2015-Oct 2017 Staff Pharmacist

Provided Immunization and Dispensed Prescriptions. Performed MTM, CMS Study and handle issues regarding drug utilization reviews (DUR), third parties, and prescriptions

Wal-Mart Pharmacy, PA Apr 2010-Oct 2014

Pharmacy Manager

Collaborated with Pharmacy supervisors and Wellness professionals on day to day operations, business goals and profit meeting. Supported in Pharmacy audits and Board of Pharmacy inspections

Successfully increased pharmacy sales and profit by 20%

Managed and maintained pharmacy in compliance with State, Federal, and Walmart rules and regulation

CVS Pharmacy, Ann arbor, Michigan Jan 2007-Mar 2010

Staff pharmacist

Managed high-volume pharmacy that processed about 500 prescriptions daily; dispensed, filled, and verified orders and oversaw issues regarding drug utilization reviews (DUR), third parties, and prescriptions

Alembic Pharmaceuticals,

Vadodara, Gujarat, India

Research associate Mar 2002 -May 2005

•Developed new tablets and capsules formulas, combining primary ingredients with various components and conducting tests to measure factors including disintegration time, hardness, and weight

Operated HPLC, UV/IR, and GC equipment, tablet compression and tablet coating devices, fluid bed dryers, double cone blenders, and blister packing machinery

Education and Licensure

Advanced Drug Safety and Pharmacovigilance Certification, Sollers College, Edison, New Jersey - 2020

Master of Science in Pharmacy (Medicinal Chemistry) Maharaja Sayajirao University, Baroda, India -Feb 2002

Bachelor of Science in Pharmacy, Maharaja Sayajirao University, Baroda, India – June 2000

Registered Pharmacist: State of Pennsylvania and Michigan

Certified Immunization Pharmacist. CPR and BLS trained – Valid till 2022

Work Authorization -- Authorized to work for any US employer without any sponsorship - US citizen

Affiliation

American Pharmacist Association

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