Email Id: ac17ph@r.postjobfree.com Mobile: +91-977*******

Address: Nr. Laxmi Dhanya Bhandar, Shivaji Ngr, Manpada, Ghodbhunder road, Thane (West)-400607, MH, IN.

Date of Birth: 21 Jun 1988; Female; Indian

To be a part of an organization where the management structure recognizes and rewards loyalty, honesty, hard work and ambition of an employee by providing growth opportunities and necessary infrastructure that could contribute to the success of the company.

Job in Pharmacovigilance Drug Safety (Clinical Research Operations)

Clinical Trial Skills

PV:

Experience in processing ICSRs and can process all clinical, spontaneous and non-interventional ICSRs on ARISg database and expertise in AGXchange and MedDRA coding.

Experience in triage, case severity in order to prioritize follow-up, case processing, narrative writing, maintain workflow management and ensures compliance of pharmacovigilance activities.

Responsible for identifying duplicate/invalid ICSRs in ARIS, reconciliation and Disposition of valid terms into the ARISg system.

Quality review of cases, following company SOPs, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate polices.

Manages adverse events and acquire knowledge in different disease and therapeutic areas

Assist in drafting product labelling (Product Monograph, Health Professional Information, Prescribing Information, and Package Insert) for regulatory submissions.

Accountable for performing the appropriate clinical assessment (including assessment of seriousness, labelling and company causality for each event) adhering to SOPs/other controlled documents and regulatory requirements.

Multitask on projects across departments including, Data Management, Medical Affairs, Research, Business Development, Remote Monitoring and Clinical Operation.

Trains and mentors new employees in pharmacovigilance.

Knowledge of ICH GCP, MedDRA, Schedule Y and ICD.

Clinical Trial Assistant (CTA):

Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.

Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.

Supporting CRAs for site management and document management

Sending the Site packages to the Site during the study life cycle (Pre-Site Initiation, Maintenance phase, Close Out).

Actively participated in audit of Clinical Operations.

Quality Control and quality check of the study documents.

Challenges for EC submission.

Remote Monitoring (Phase III trial)

Key skills:

Ability to work under pressure and convey a sense of urgency.

Ability to use simple language based on target audience adapt changes.

Team player with ability to function in a multi-disciplinary environmental and promote collaboration.

Excellent communication, documentation, organizational and interpersonal skills.

Decision making, problem solving and advisory role.

Fluency in English (spoken and written).

Confident, Self-Learning and Hard-working. Versatility and Goal oriented.

Professional Details

Jun 2016 - Ongoing Working as Pharmacovigilance Safety Associate and CTA (currently ongoing with Phase III trial) in THINQ Pharma CRO, Mumbai

Dec 2014 - Mar 2016 relevant experience as Assistant Pharmacist Manager in Zeni Enterprises

Apr 2012 - Oct 2014 Worked as Pharmacovigilance Scientist Level-I in TATA consultancy services for Roche Drug Safety, Mumbai

May 2006 - Jul 2008 Worked as Assistant Manager in PESA (Pradhan’s Educational Society of Academics), Mumbai

Summer Internship Project

May 2008 - July 2008 Worked as a trainee chemist and experience in selling medicines, inventory management and handling customers at Retail Shop, Mumbai

May 2010 - June 2010 Worked as trainee in organisation and relevant experience in quality assurance, quality control and various other aspects of the Pharma organisation at Shreechem Pharmaceuticals, Mumbai

Clinical Trial Skills/ Health care Skills

Pharmacovigilance

Clinical Trial Operations

Clinical Data Management

Medical Coding

Remote Monitoring

Types of cases handled

IRT [Inbound Receipt Triage], AGXchange

ARISg 6.0

Serious Spontaneous

Non-serious Spontaneous

E2B cases

Clinical trial cases

Pharmacovigilance database/systems experience

Line Listing cases

Academic Summary

2012 PGD in Clinical Research from Academy for Clinical Excellence, BCP, Mumbai.

2011 B. Pharm from University of Mumbai with 1st class.

2008 D. Pharm from MSBTE, Mumbai with Distinction.

2006 12th from Maharashtra Board with 2nd class.

2004 10th from Maharashtra Board with 1st class.

Computer Skills

Microsoft Office (Excel, Word, Power point, Outlook), proficient in Internet search.

Typing speed 40-50 words/min

Certifications

Delegate in National Seminar on Recent Trends in Pharmaceutical Sciences.

Participated as Volunteer organized by IPA.

Participated in the Health Check Up camps organized at our college.

MCC-A Grade Certificate of a Cadet Rank in Schooling in year 2001

Obtained several certificates in Sports in School

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