RINKAL SANGANI

*** **** ****** *****

Marlton, NJ-08053

acha82@r.postjobfree.com

Cell: 848-***-****

Objective:

Experienced HCP, aspiring for Drug Safety Associate position in Pharmacovigilance department to make a significant contribution to the Safety team; that will promote growth, stability and opportunity for advancement utilizing experience of Medical & Health Science, expertise on Argus Safety .

Strengths:

Extensive knowledge of Drug Safety and Drug development process and procedures.

Knowledge of ICH-GCP,FDA guidelines.

Knowledge of scientific terms and Medical terminology.

Knowledge of Oracle ARGUS database.

In depth knowledge of MedDRA and WHO Drug coding dictionary.

Proficient in data entry and drug safety database.

Self-motivated, goal and detail oriented, having excellent written and verbal presentation & communication skills.

Organized, Hard working and dedicated with good moral character.

Ability to analyze large data sets.

MRE,Triaging, Case processing and Data entry.

A team player, quick learner who can formulate independent decisions.

Strong ability to work in a dynamic and highly demanding environment.

Good computer skill like a MS word,excel and esp ARGUS.

Professional Experience :

Nov 2013-Oct 2014

Noven Pharmaceutical,New york 10118

As Drug Safety Associate.

Review Medical records and Extract Medical relevant information to cases in accordance with US FDA Regulations

Prioritize cases based on seriousness of adverse events in accordance with SOP and regulatory guidelines.

Evaluate and document event terms,case classification,Validity and seriousness of case.

Perform Triage on incoming cases eventually to determine the regulatory clock start date and time frame for FDA submission and perform data entry into the safety database for initial or follow up cases from pre and post marketed drugs.

Apply knowledge on MedDRA coding for issuing queries for all discrepancies found while coding on situational case scenarios on following concepts.

Reviewed and Create comprehensive and accurate narrative for both serious and non serious cases procured from relevant,related information from various documents.

Performed active follow up via telephone contact with consumers and health care professionals.

Perform case processing and FDA reporting Medical devises.

Perform Quality control review after completed the case and before route to senior level department.

Resolution of queries of pending cases.

Reconcile serious adverse events reported during the conduct of a clinical research trial in Clinical Database with Safety Database.

Assist in to prepared a PSUR reports,annual reports.

Assist in to signal detection,Drug labeling edit check.

May 2013 - Oct 2013

Navinta pharmaceutical,Ewing Township,NJ 08618.

As a Pharmacovigililance Case Associate.

Initial data entry of case reports in to safety database - Assessing case by seriousness,expectedness and causality.

Collected,documented and processed adverse event(AE) reports from various sources such as clinical trial,post marketing and Literature sources.

Performed detailed review of source documentation during Triaging,Data entry and Case processing event in accordance with SOP’s.

Exercised clinical judgment using knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness,expectedness,causality and listedness.

Reviewed and manually updated system generated auto narratives.

Performed data entry after extracting and analyzing medical information from records maintaining accuracy and consistency.

Performed manual coding of AEs and verified for appropriateness in MedDRA dictionary and WHO drug conventions.

Performed Periodic reconciliation of AEs originating from various trials and communicated the discrepancies with relevant department for updating the database.

Oct 2012- Apr 2013

Qtec solution,Somerset,NJ

Intern(Training) As a Advance Drug Safety Associate

Gained hand on experience on Extraction medical relevant information from provided source documents like Medical records.

Prioritized the case and perform Triage by assessing the seriousness,expectedness and causality to determine clock start date and time frame foe FDA submission.

Perform Case processing including Data entry,coding and review automatic prepared narrative and find out any missing information so can suggest further follow up needs for particular case or not.

Case processing and FDA reporting of Medical devise.

Learn and perform Quality control review of prepared case and reports.

Perform SAEs Reconciliation.

Resolution of queries of pending case.

Perform exercised and get hands on experience of CIOMS line listing, Signal detection,drug labeling edit check,PSUR reporting and case follow in SUSAR categories or not and need to notified FDA or not.

May 2011- Apr 2013

Lab Corporation of America,Voorhees,NJ 08053

As a site coordinator of PSC and Phlebotomy Tech

Manage Patient Service Center included Manage work flow can satisfied Patients as much as we can and corporate gets less complains form patients.

We were really busy site so by Manage the Schedules of my team so it’s provide minimum work stress environment to them.

Update and generate Monthly reports,PSC’s documents with new company policies.

Give training to my team for any update related to work from company and federal.

Generated and send waiting time reports,complains of Patients and Complications occurred during a day to Supervisor,Manager and corporate by fax and an Email.

Perform data entry,blood draw and process the specimens as per work flow.

Jun 2009-Jan 2010

Cyclone Pharmaceutical, Pune, India.

As a Medical record Extraction coordinator.

Receive information from clinical trial department and research laboratories and perform data entry.

Logging in received clinical research forms and transferring data from the forms into the database.

Find out any missing or wrong information collected or entered previously.

Performed active follow up via telephone contact with consumers and health care professionals.

Jun2008-May2009

Mahagujarat Hospital,Nadiad,India

As Physician Assistant.

Examine and record the height,weight,vital signs and EKG of the patients.

Obtaining full medical history of the Patients.

Perform general and systemic physical examination of the patients.

Administer IV,IS and IM injections.

Performing dressing and stitches of injured Patients.

Prescribing Medicine etc...

Education:

Advance Drug safety associate training and internship

From Qtec solution Oct 2012- Apr 2013

Certified Drug Safety Associate Jun 2012- Sep 2012

From Clinical research academy of America

Bachelor of Medicine and surgery Sep 2003-Jun2009

From Sardar Patel University,Anand,India.

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