DISHA PARIKH

***** ********* *****, ******* ****, CA. 91381 Email: ac0bdy@r.postjobfree.com Cell: 661-***-****

CAREER OBJECTIVE

An accomplished and qualified Pharmacy professional looking for an opportunity in pharmaceutical realm and Regulatory Affairs that will utilize my scientific and technical skills in areas such as drug safety, regulatory and pharmacology as well as communication skills in direction towards overall success of the organization.

AREA OF EXPERTISE

Skilled in Post-marketing Drug safety surveillance with expertise in Individual case safety reports (ICSR).

Knowledge on functions and roles of different regulatory authorities such as MHRA, BfArM and USFDA.

Worked closely with risk management, aggregate reports, signal detection and quality assurance team.

Knowledge and understanding on IND, NDA, ANDA, ICH Guidelines, cGMP, GCP, GLP and GDP.

Proficient in ARISg safety database.

MedDRA coding, strong understanding of medical terminology, medical content and medicine

AE/SAE management, ICH safety reporting regulations and guidelines

Profound knowledge on mechanism of action and common adverse events of drugs and its classes.

Team player with excellent skills in building and maintaining relationships internally & externally.

Ability to demonstrate new ideas as well as pick up new concepts.

Multi-tasker with ability to work with detail orientation under pressure.

Excellent written and verbal skills.

PROFESSIONAL EXPERIENCE

APCER Life Sciences (Client: Bristol Laboratories) Ahmedabad, India

Pharmacovigilance Associate (EU-Operations) Jun 2015- Apr 2017

Triaged ICSRs from sources like Medical Literature Monitoring (MLM) service, Embase and PubMed

Performed quality review of processed ICSRs from Health Authorities and MLM service (review of complete data entry, drugs characterization and events selection, medical coding (MedDRA), dechallenge-rechallenge, causality assessment, expectedness using SPC and PIL, assessment for expediting, narrative writing etc.)

Provided feedback and organizing weekly QC meeting for quality improvements

Performed case processing (Health authority and literature cases for drugs) including duplicate check, data entry; drug coding using company product dictionary (CPD), MedDRA coding, listedness assessment using SPC and PIL, narrative writing and report scheduling in accordance with companies controlled documents (e.g. SOPs, WIs, Guide) and guidelines

Managed timely submissions of expedited reports through ARISg safety database in order to maintain regulatory compliance.

Prepared and maintained internal filing systems; archives safety files and scans source information for archival in electronic systems. Collaborate with internal departments to supports and develop standard operating procedures/working practices/collection forms and adheres to company and departmental SOPs as required

Prepared Group Training Record Forms (GTRF)

Evaluated case for deletion; Preparation of deletion annexure and raising and preparation of change control form (CCF) for same

Delivered training and mentoring team members for ICSR case processing and triaging

Shree Swaminarayan Sanksar Pharmacy College Ahemdabad, India

Assistant Professor Jul 2014 - Jun 2015

Taught Pharmacology and Human Anatomy and Physiology to undergraduate students

Assisted senior professors in preparing curriculum and presentations for the classes

Engaged in student recruiting, program development, and program assessment

Used technology in teaching, and publishing study-related materials on college website

Prepared and gave lectures and graded papers and tests

EDUCATION

Master’s Degree, Pharmacology and Toxicology May 2014

K.B. Institute of Pharmaceutical Education & Research

Academic Project: Effects of Trans Fat in Postmenopausal Female Rats Fed with High Fat Diet

Bachelor’s Degree, Pharmacy June 2012

Shree Swaminarayan College of Pharmacy

PUBLICATION and PRESENTATION

“Role of Estrogen and Progesterone in Human Disorders- An Overview”, International Journal of Pharma Research and Review, March 2014.

https://www.ijpr.in/Data/Archives/2014/march/060*******.pdf

Presented poster on “Evaluation of anti-diabetic and anti-obesity activity of cochineal carmine (PTP1B inhibitor) in high fat diet fed rats” in 45th Annual Conference of Indian Pharmacology Society

REFERENCES AVAILABLE UPON REQUEST

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