PRIYA SHARMA

Address: #**, *** ****, *** *****, Mobile: +91-997*******

1st Block Koramangala, Bangalore- 560034, India E-mail: acupqk@r.postjobfree.com

Presently working in Pharmacovigilances dept. at Quintiles, Technologies India Pvt. Ltd, Bangalore, India as an Associate Operations Specialist from 02-March-2015- 09-Mar-2016.

Have worked in Pharmacovigilances dept. at Accenture Services Private Ltd, Bangalore, India as a Senior Process Associate from 03-March-2014 to 28-February-2015.

Have worked in Regulatory Affairs department at Micro Labs Ltd, Bangalore, India as an Executive from 19-Jul-2012 till 28-Feb-2014.

Have worked as an intern from 01-June-2011 to 30-November-2011 in scientific writing at Novartis Healthcare Pvt Ltd, Hyderabad, India.

PURPOSE

Responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.

Roles and Responsibilities

Pharmacovigilances

Trained in Sceptre safety database.

Initial receipt, Database searches as necessary. Registry and Triage of incoming cases to determine seriousness for prioritization of daily workflow.

Completion of case processing (case data entry, labeling, approval numbers, manual Coding, narrative writing) and quality review.

Clarification of illegible information from the Local Safety Officer or Call Centre and Customer communication as per the project requirement.

Discuss source documents, coding conventions and ad-hoc queries with Pharmacovigilance Physician.

Preparation of deviation memo as necessary

Request deletions/Admin edit requests as necessary

Other Case processing related activities (e.g. review of consistency checks, reconciliation etc)

Pharmacovigilances

Trained in Argus safety software.

Transcribe cases, write narratives and perform medical coding of the data using CDD, WHODD and MedDRA.

Ensure timely and accurate data entry of cases to meet regulatory reporting requirements.

When assigned, peer review data entered cases to verify accuracy, consistency, and compliance with process requirements.

Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.

Identify any additional queries for any missing data or clarification and document appropriately in the global safety database with a brief description of the additional information needed.

Work with all other onshore and offshore therapeutic area and shared service roles to promote consistent operations.

Understand and work to the current SOPs and SDs, ensuring deviations are documented appropriately

Meet productivity and quality targets.

Regulatory Affairs

Writing & reviewing of labels like summary of product characteristics (SmPC), patient information leaflets (PIL).

Writing the supportive documentation Clinical & Non- Clinical Overviews in CTD format as per ICH guidelines.

Artwork preparation [label, secondary packaging like International Package Inserts (PI)].

Post Marketing Surveillances (PMS).

Clinical Rationales.

Accountable for timely, reviewing, compiling & submission of dossiers of different products as per country’s guidelines for Product Registration in ROW market for African countries like Zambia, Ivory Coast, Senegal, Cameroon & Nepal.

Updation of registration dossiers, evaluation of the queries received from respective country agencies.

Preparation of Query Responses of above related applications.

Scientific Writing

As per my work experience, I had worked across several deliverables like:

Slide sets.

Manuscripts.

Pub alerts.

Abstracts.

Posters.

Review articles.

Literature search using databases like Pub med, Ovid, Embase, International Pharmaceutical abstracts and

Bio sis.

ACHIEVEMENT

Approval of Drug clearances in Philippines of more than 40 products.

Approval of Overview, Pack Insert, SmPC, Expert Report, RMP in ROW market of more than 80 products.

EDUCATION:

Master of Pharmacy (Pharmaceutics): Al-Ameen College of Pharmacy, Bangalore, India

Aggregate 66.7% passed out in 2011.

Bachelor of Pharmacy: Krupanidhi College of Pharmacy, Bangalore, India

Aggregate: 65.5% passed out in 2008.

“Design and development of mouth dissolving tablet of cephalexin”

PAPER PRESENTED /CONFERENCE ATTENDED:

Presented poster session at 62nd Indian Pharmaceutical Congress 2010 –“Taste masking of cephalexin by microencapsulation technique”.

Participated in the poster session at 62nd Indian Pharmaceutical Congress 2010-“Development of Time dependent delivery of Metronidazole for colon targeting”.

Attendee at the State level conference on Inflammatory Diseases: Basic Knowledge of the Diseases, Novel Treatments, Synthesis of Drugs and marketing.

Attended a Training programme on Good Laboratory Practices.

ADDITIONAL QUALIFICATION:

Certified with Intellectual Property Management course held by Al-Ameen College of Pharmacy, Bangalore, India.

Certified with “Hands-on Training Programme in Pharmaceutical Management” industrial course conducted by Klenzaids Institute of Biopharmaceutics, Gujarat, India.

Undergone industrial training in tablets, liquid orals, QC & QA departments at Duckbill private limited, Kolkata, India.

Undergone industrial training at “Formulation Development Centre in Syngene International Ltd,

Bangalore, India.

Certified training in Good Clinical Practice (GCP) Module 1-9.

OTHER ACTIVITIES:

Hands-on experience on HPLC, Extruder Sper’oidizer, Tablet punching machine, Dissolution apparatus, FTIR and UV-Visible Spectrophotometer.

MEMBERSHIPS:

Member of the KSPC (Karnataka State Pharmacy council)

Life member of APTI (Association of Pharmaceutical Teachers of India)

COMPUTER SKILLS:

MS Office (MS Word, Power Point and Excel).

Experienced in Bookmarking, hyper linking to various types of document.

PERSONAL DETAILS:

Date of Birth: 10th Oct 1986.

Sex: Female.

Marital Status: Single.

Languages Known: English, Hindi and Punjabi

DECLARIATION:

I hereby declare that all the details furnished above are true and correct to the best of my knowledge and belief.

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