Dipali Joshi

*** ******* **,

Murphy, Texas, ****4

Email: adnpvy@r.postjobfree.com

214-***-****

EDUCATION:

●M.Pharm (clinical pharmacy), V.N.S.G.U-Surat, India, 2010

●B. Pharm, V.N.S.G.U-Surat, India,2008

I have Total 6 years of experience in clinical research as clinical research coordinator and also as safety data analyst in pharmacovigilance.Worked as Pharmacy Technician part time.

Key Skills:

Logical approach to problem solving.

Ability to work independently as well as in a team environment.

Strong communication skills, flexibility and creativity.

Worked on ARIS G, ARGUS, Oracle 4.6, Inform Database Medidata & Rava

ICH - GCP trained

Employment -1

Organization: IQVIA,4820 Emperor Blvd, Durham, NC 27703, United States

Type: Full time contract, work from home (March 2021 till now)

Designation: Operation specialist 1

Job description:

Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines

Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.

Liaise with local IQVIA offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting. Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.

Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data. Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs)and project requirements. Mentoring less experienced or newer staff members.

May provide an oversight role to impart technical and process information to the LSM point of contact and members of the operational team. May provide an oversight role to perform operational and collaborative LSM tasks as directed by Lifecycle Safety Infrastructure.

Participate in team meetings and provide regular feedback to operations team manager and life cycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.

Ensure compliance to IQVIA high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.

Participate in training across Lifecycle Safety service offerings. Provide project-specific operational process training to junior team members, monitors and investigative site personnel, as appropriate. Liaise with different functional team members, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address operational project issues.

Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable. Perform other duties as assigned.

Employment-2

Organization: Good sense pharmacy,San antonio,Tx

Designation: Certified pharmacy technician,Remote( Aug 2018- Oct 2019)

Job Description

Perform prior authorization for drugs

Perform MTM (medication therapy management)

EMPLOYMENT-3:

Organization: Cognizant technology solution, Airoli, Navi Mumbai, India

Designation: Drug safety Specialist (November 2012 to june 2014)

Job Description (Safety Data Analyst) Cognizant technology solution, Aeroli, Navi Mumbai, India :

Receive information on adverse events, perform initial checks, search database to prevent duplicate entries, Perform triage and create case file and initialize received drug safety reports in the safety database.

Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.

Narrative writing, coding, data entry, query writing, Medra coding

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

Drafted narratives summarizing the essential details of the case. Use medical dictionaries and business guidance's to code medical history, drugs and adverse event terms.

Identify clinically relevant information missing from case report and facilitate its collection (in consultation with marketing companies as required) and also request for follow-up.

Forwarding the case for regulatory (FDA) submission

Escalated identified unresolved issues to Group Lead on time

Participated in Client interactions and Teleconference if required

Knowledge in theory and practice of FDA Pharmacovigilance legislation, adverse events reporting, case entry, MedDRA coding etc.

Complying with SOPs and ICH-GCP

EMPLOYMENT-4:

Organization: Hemato oncology clinic, Ahmedabad, Gujarat g, India

Designation: Clinical research coordinator (November 2010 to November 2012)

CLINICAL RESEARCH EXPERIENCE

Job Description( Clinical research coordinator)

Filling up Site Feasibility

Arranging and participating in Site Qualification Visit, Site Initiation visits

Taking Informed consent of potential patient in accordance with ICH GCP

Counseling study subjects and giving instructions as per study protocol, usage of drugs, upcoming

visits, taking study specific follow up etc.

Maintaining drug accountability and relevant logs of specific trial

Maintenance of study files, Source documents and all other Study related files

Performing all the Ethics Committee submissions, approvals and notifications in a timely manner.

Dispatching all Ethics Committee Documents, newsletters, notifications, safety reports to the Ethics

committee Chairman and other members of the committee in timely manner

Maintaining paper CRFs and electronic CRFs

Coordinate Data Query Resolutions

Followed up regularly with the Site Monitor, Medical Monitor for the resolution of issues.

Coordinate with several Centralized Vendors for Radiology and Laboratory workup

participating in Site Close out visits

Preparation of site SOP

Clinical Trials in Phase II – III studies, involving Therapeutic areas in Oncology- including blood

cancer and solid tumors

Attended 2 investigator meetings ( Pfizer, Astrazeneca)

Trainee clinical research coordinator SEP 2009 to FEB 2010, HCG Medi-Surge hospitals, Ahmedabad,

Gujarat- India

THERAPEUTIC EXPERIENCE:

● Oncology: CML, CLL, Solid tumors- Prostate cancer, Breast cancer, NSCLC, Pancreatic cancer

● Endocrinology: Diabetes, Gout

PERSONAL DETAILS

Date of birth

16th Jan, 1986

Gender

Female

Nationality

Indian

Marital status

Married

Spouse

IT professional

Language known

English, Gujarati and Hindi

Hobbies

Reading, Traveling, listening music

Strength

Positive attitude, Self-confident, Quick learner, Friendly, Optimistic

Foreign country Visits

France, Hong Kong, India

CERTIFICATION

●ICH GCP trained

●Pharmacy technician (PTCB)

Contact this candidate