JAIMIN D BHATT

MSc. Toxicology */*, MARUTIKRUPA SOCIETY

Email- adiw86@r.postjobfree.com ANDADA, ANKLESHWAR,

Phone #: 097******** GUJARAT- 393010

AREA OF INTEREST:

I am looking forward to be a part of a leading organization as a Pharmacovigilance /Drug Safety Associate.

WORK EXPERIENCE

Pharmacy technician (JAN 2012 – DEC 2012)

Britannia pharmacy, london

Drug safety associate (OCT 2013 – FEB 2017)

TCS, Mumbai, India

Senior Drug safety associate (From MAR 2017 till date)

Zydus Cadila, Ahmedabad, India

Role Description:

Completing pharmacovigilance (PV) activities in accordance with company Standard Operating Procedures (SOPs) and Working Instructions (WIs).

Process Individual Case Safety Reports (ICSRs) and ensure timely completion of all case processing activities in line with regulatory and company requirements.

Code adverse events accurately using MedDRA

Determine expectedness /listedness against appropriate label

Ensure that case narrative comprises correct and appropriate safety information.

Determine and perform appropriate case follow-up, generating follow-up letters.

Ensure compliant safety reporting in accordance with US and international reporting regulations, SOPs and safety processing guidelines set forth by departmental management team and the client.

Tracking and submission of the cases as required.

Provide information and conduct Pharmacovigilance training to company staff and third party providers.

Reconciliation of all adverse event reports from Third Party service providers, distributors and licence partners.

Global literature review to identify potential ICSRs and to identify safety information in accordance with company SOPs.

Maintain awareness of PV regulatory requirements and developments.

Management of departmental email inbox.

Participate in inspections and audits when required.

Assist with related administrative and procedural activities as required or requested.

Ensure compliance with the training plan provided for the role.

EDUCATION

.

Advance PG diploma in clinical research and pharmacovigilance (APR 2013)

Biomed informatics, Medwin hospital, Hyderabad, India

MSc Toxicology (SEP/ 2009 to OCT/2010)

University of East London, London, UK

Bachelor of Pharmacy (SEP/2004 to OCT/2008)

Rajiv Gandhi University of health science, Bangalore, India

KEY SKILLS

Well-organized, detail-oriented and excellent follow-up skills

Excellent oral and written communication skills

Ability to manage stress, time and people effectively

Having hand on experience of ARISg, IPS, PvNet and Argus safety Database

Well versed with Microsoft Office (Excel, Word & PowerPoint)

DECLARATION:

I hereby declare that all the statements made in this resume are true and complete to the best of my knowledge and belief.

Place: - Ahmedabad Mr. Jaimin Bhatt

Date:

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