Medical Customer Service

Sejal Patel

**** ******** ******* ***** *** # *09, Winston Salem, NC, 27107 973-***-**** ac1ano@r.postjobfree.com

Medical Communication/Medical Administrator

Over 3 years of Scientific Affairs Specialist, Regulatory Reporting Specialist, Pharmacovigilance and Medical Information Process Administrator experience within the Tobacco Industry, Medical Device, & Pharmaceutical Industry.

Area of Experience:

Endoscopy

Women’s Health

Pediatric Health (Emphasis in ADHD)

CNS Medication

Tobacco - Cigarettes & Cigars

Skill Set

Systems: TrackWise, WebEx, Cube Dialer Documentum, ERP (Micromedex), Concur, IRMS, PISA (MS ACESS), EMR – AHMS, and MD-Docs

Skills: Medical Terminology, Metrics Reports, Cross Reports, Narrative Writing, Quality Assurance Assessment (QAs), FDA Regulations/ICH and GCP Guidelines, Discrepancies/Resolution, Managed Department Budget, Managed & Tracked Source Documents, and Post Marketing Drug Safety Query.

Courses: Regulatory & Ethical Requirements in Clinical Investigations (Rutgers Online), Medical Terminology, Anatomy and Physiology, Ultrasound Physics, Nursing Procedures, Abdominal and Small Parts, Gynecological, Calculus I, II, III, Differential Equations, Probability & Statistics, Chemistry I, II, Computer & Society, Multimedia Information Systems, Advance Information System, Sociology, Economics, Principles of Management, Principles of Marketing and Principles of Accounting

Office: Word, PowerPoint, Excel, OneNote, Adobe Aerobat and MS Outlook and Mozilla Thunderbird

OS: Windows 7/8, 10, XP, Vista, and Mac OSX

Fluent in English, Gujarati & Hindi

Outstanding organizational skills and teaching skills.

Excellent communication skills.

Excellent problem analysis & problem solving skills.

Extremely motivated, dedicated and hardworking.

Outgoing, friendly and sociable.

Enjoy working with computers and people.

Multitasking and quick learner.

Strong background in the sciences, computers, customer relations, and logistics.

Education

Healthcare Training Institute, Union, NJ

Certificate: Diagnostic Medical Sonography, Jan 2011

ARDMS – American Register Diagnostics Medical Sonographer

New Jersey Institute of Technology, Newark, NJ

Degree: BS, Information System (IS), May 2006

Minor: Management, May 2006

Professional Experience

ITG BRANDS, LLC

420 N. English Street, Greensboro, NC, 27405 (Contract – FT) 4/2017-Present

Scientific Affairs Specialist

Provide support to and responsible for assessing and managing the regulatory impact of critical interfaces between PIC and internal and external stakeholders and Third Party Regulatory Engagement processes and management.

Oversees and responsible for regulatory submissions and developing timelines and processes for the submissions.

Provides support to the Manager, Scientific Affairs and Director, Regulatory and Scientific Affairs and is responsible for assessing and managing the regulatory impact of critical interfaces between RSA and internal and external stakeholders, and Third Party Regulatory Engagement processes and management.

Oversees the management of the processes surrounding the regulatory submissions and approvals with any entity outside of RSA, including Imperial Group function (Product Science) or legal or regulatory consultants to review the regulatory products.

Ensuring providers of scientific data or narratives on behalf of the Company are provided the right requirements to meet standards and understanding the project management timelines in order to ensure the Company has the quality and time to approve any submissions in a rigorous manner.

Interacting routinely with various internal groups and external consultants (e.g. Product Science, Integrated Compliance and Audit, Product Development, Operations, Marketing and Legal) to ensure all regulatory submissions and responses to the FDA requests for information are properly organized, appropriate and scientifically accurate and completed in a timely manner.

Manages the data collection, review and submissions of reports and other relevant information to the proper authoritative areas and prepares relevant submissions to regulatory agencies by maintaining and utilizing the data repositories for the completion, drafting for approval and conveyance based upon the correct schedule and in the technically correct details specified by the external requirements.

Responsible for authoring, organizing and updating the scientific and technical portions of FDA Premarket Tobacco Applications such as Substantial Equivalence and Exemption Requests, Modified Risk Tobacco Product Applications, and responses to FDA requests for information.

Adheres to general standards to promote a cooperative working environment by utilizing communication skills, interpersonal relationships and team building.

COOK MEDICAL

5941 Grassy Creek Blvd, Winston Salem, NC, 27107 (Permanent – FT) 10/2016-3/2017

Regulatory Reporting Specialist

Review and assess product complaints for Regulatory Reporting. This includes Adverse Event Reporting (MDR, Vigilance) and associate correspondence to applicable Regulatory bodies.

Assess complaints for adequate information to determine if event meets Regulatory Reporting requirements.

Utilize appropriate complaint software system for processing complaints to/from distribution centers and QE Investigation functions.

Generate appropriate regulatory reports based on assessment.

Communicate with other Cook Companies globally as necessary for reporting.

Generate responses to inquiries on AE reports from various global regulatory authorities.

Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.

Assist in coordination of Recall administration activities between manufacture and distribution centers.

Work & interact effectively and professionally with and for others throughout various levels of global organization.

Excellent problem solving skills and work in collaborative and independent work situation and environments with minimal supervision.

PAREXEL

433 Hackensack Ave, Hackensack, NJ (Permanent – Full Time) 01/2015-9/2016

Pharmacovigilance Scientist & Medical Information Process Administrator

Respond to unsolicited verbal and written medical information inquiries from HCPs and consumers in a prompt, accurate, and compliant manner.

Provide after hours medical information coverage.

Collect and report adverse event data (AE/SAE) and product complaint data (PQC) to respective departments within required timeframe.

Thoroughly and accurately document cases in medical information database, consistent with Client operational procedures.

Coordinate with team members to ensure adequacy of Contact Center coverage during business hours.

Meet or exceed service levels and targets for Med Communications and Client.

Regularly attend product training sessions to maintain awareness of and knowledge of relevant medical information updates.

Perform medical writing (Case Narrative writing)

Provide customer service to consumer, doctors, and pharmacists on Daytrana, Brisdelle, Minivelle, Combipatch, and Pexeva based on MI, PQC, Marketing and AEs.

Managing inbound and outbound correspondence (phone, fax, email and hard copy/postal mail), coupons, package insert, response letter and related administrative tasks.

Handling and Triaging escalation calls related to medical information, marketing inquires, product quality complaints and AEs.

Entering product quality complaints in Noven’s database TrackWise.

Compilation/retrieval of various types of information and data required by the Project Manager/senior management.

Preparation of various Excel spreadsheets (Escalated US call details, Everyday mailing expense log, Cross report request, Meetings logs and minutes, Medical information request, and Sales rep request per client/management requirements.

Maintaining a good working knowledge of relevant client’s procedures.

Maintaining an awareness of global regulatory requirements and reporting obligations.

Performing Quality Assurance Assessment (QAs) for MICC Team

Coordinate department shift schedule for the team.

Research, create, edit and update SRDs and Medical Information request for HCPs.

Attend weekly meeting with clients and keep record of meeting minutes and meeting logs.

Liaise with MICC team and client (Noven).

Create an instruction “Cheat Sheet” for MICC team.

Create cross report as needed.

ACTAVIS

400 Interpace Pkwy, Parsippany, NJ (6 Month Contract) 08/2014-01/2015

Medical Communication Coordinator

Provide customer service to consumers, doctors and pharmacists on more than 800 products.

Work well under pressure; able to handle high call volumes to meet resolutions.

Answer calls and enter cases to IRMS as well as refer cases to specialist.

Run daily MIRES query and process the corresponding letters for pharmacist review.

Identify adverse events and quality defects of products and transfer to appropriate department.

Check medical communications voicemail and then enter all messages into IRMS.

Check the fax machine and email to enter cases into IRMS.

Communicate with customer relation and drug safety departments to reach the consumer expectation.

ASSOCIATES IN PRIMARY CARE

25 East Willow Street, Millburn, NJ (Permanent – Full Time) 06/2012-7/2014

Medical Receptionist and System Project Manager

Greet patients, visitors and pharmaceuticals representatives.

Ensure that patients and visitors are educated on clinical procedures and policies.

Work well under pressure; able to handle high call volumes to meet resolutions.

Help patients to refill their RX using EMR (AHMS) system.

Prepare and mail paperwork for MD-VIP patient’s physical.

Prepare paperwork for Medicare patients based on their visits.

Prepare referrals and patient eligibility using Navinet and Carecore.

Verify health insurances such as Aetna, BCBS, Medicare, Oxford and United Healthcare.

Answering HEAVY phone calls to solve patient’s questions and transferring calls to the appropriate department and person.

Scheduling appointments for patients using EMR (AHMS) system.

Respond to e-mails and correspondence.

Update patient’s records.

Scan medical documents.

Organize, track, save and order office supplies using Online Ordering System “www.premierplus.biz”

Manage inventory of office supplies and equipment.

Organize, book and manage lunch schedule.

Take Patient demographics and insurance information to register patients into AHMS.

Post payments into AHMS system.

Swap drives to backup the data.

Install, test and run EMR-AHMS system on computers.

Install, test and run printer on computers.

Provide help with any technical related work.

DR. ALEX COCOZIELLO OB-GYN

1 Broadway # 303, Elmwood Park, NJ (Per Diem) 02/2011-05/2012

Ultrasound Technician

Entered patient’s information & data on GE Ultrasound machine.

Explained examination procedures to patients.

Performed Ultrasound scans on patients for GYN, OB 1st trimester.

Measured anatomy accurately and document pathology shown to Dr. Alex.

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