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Pharmacovigilance Specialist

Location:
Toronto, Ontario, Canada
Salary:
50000
Posted:
February 06, 2019

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Resume:

VANI BHAGWAT

Ph: +1-647-***-****

Email: ac8epn@r.postjobfree.com

LinkedIn: https://www.linkedin.com/in/vani-bhagwat-b03b0642/

SUMMARY OF QUALIFICATIONS

Overall, around 6 years of experience working as a Pharmacovigilance Professional achieving high-quality and productivity in clinical trials.

More than 3 and half years of experience working as a safety lead for multiple protocols in different therapeutic areas like interventional cardiology, peripheral intervention, cardiac rhythm management and oncology trials.

Worked closely with multidisciplinary study teams in all aspects of safety data processing, management and reporting.

Worked as a SME (Subject Matter Expert) for cardiovascular clinical trial.

Excellent command over Clinical Trial process and Clinical Development Plans (safety plan and complaint plan).

Proficient in GVP, ICH GCP, MHRA, Canadian Food and Drugs Act, and US FDA guidelines.

Experience in safety database management and Adverse Event/Serious Adverse Event coding with MedDRA and drug coding with WHODD.

Proficiency in narrative writing by extracting relevant information from the case reports/source documents.

In depth knowledge of ARGUS and MEDIDATA RAVE databases.

Working knowledge and understanding of various adverse event reports such as SUSAR, PSURs.

Ability to prepare and present the safety data to clients

Excellent written and oral communication skills with strong interpersonal and organizational skills.

Analytical, accurate, detail-oriented, and proficient in MS Office.

Ability to prioritize, organize and multi task assignments adhering to strict timelines.

Self-motivated focused achiever who can work in both team as well as an individual contributor with excellent problem solving skills.

AREAS OF EXPERTISE

Database:

1.Medidata RAVE (eDC system)

2.Argus version 5.0 (Safety database)

3.eCASE (Adjudication process)

4.DRU (Data Reconcile Utility) Report

5.CMCR (Clinical Management Control Reports).

RA Reporting: Health Canada forms, BfArM, Austria Reports, CFDA.

Operational Plans: Development of Safety Plan and Complaint Plan.

Microsoft Office: Word, Excel, PowerPoint.

Adobe pro

WORK EXPERIENCE

Senior Operations Specialist

IQVIA (Quintiles), India October 2012 – August 2018

Responsibilities:

Receive, triage, review and process adverse event data from various sources on time, and meet quality standards.

Performed review of SENR (Safety Event Notification Report), Source Document review, Case entry in Argus Database, Expedited report processing, Narrative Writing, Dossier preparation, Query creation follow-up and answered query report review.

Performed Adverse Event coding with MedDRA and drug coding with WHODD.

Reviewed adjudication results in eCase database.

Reporting to RA (Regulatory Authority): Health Canada, BFaRm, Austria Reports, CFDA, MDD (Medical Device Directory).

Participated in risk management activities and regularly reported to project stakeholder(s) on cumulative findings.

Review of CMR (Clinical Management Report) and MMR (Medical Management Report) provided by biostatics.

Participated and presented the data in UAT meetings & client calls within assigned deadlines.

Presentation of data on safety events and safety thresholds to clients using CMCR (Clinical Management Control Reports): database.

Contributed in project start-up activities: To Prepare & update Safety & Complaint Plan on a timely basis, to participate in CRF and CSR review for safety related issues, to review and collaborate with client for regulatory/ ethics committee reports and creation of Adjudication builder forms.

Managed work allocation, tracking, QC of daily work & workflow management within the team.

Managed project metrics for the allocated protocols, drafting project instructions /guidelines and assisted in implementation of new processes.

Performed Data Reconciliation Utility (DRU) as per the protocol and provided the same to project management.

Provided feedback to Operations Manager on any challenges/issues or successes.

Ensured smooth transition of new studies and activities with quality.

Managed close out activities as per the defined timelines.

Collaborated with Project team (both External and Internal) from start up through close out.

Processed Safety data according to applicable regulations, guidelines, procedures and project requirements. Ensured compliance to high quality standards.

Read and acknowledged all necessary standard operating procedures (SOPs) and customer SOPs as required. Ensured all required training is executed in a timely fashion and documented.

EDUCATION & PROFESSIONAL DEVELOPMENT

Master of Science in Medical Pharmacology from Manipal University, August 2012

Professional Diploma in Clinical Research - Catalyst Clinical Services Pvt. Ltd - August 2011

Bachelor of Science in Bio-technology from Mangalore University, June 2009

NOTEWORTHY ACCOMPLISHMENTS

Bravo Award : Snapshot completion (2017, 2018), Start-up activity completion for CRM and PI trials 2018

Protocol champion: PI protocol 2017 and China Protocols 2016

Best mentor award: 2015 and 2016

Applause award for independent contribution and efficient handling of the protocol activities 2014

Applause award for early completion of snapshot cases 2013

Applause award for being a fast learner, taking up new responsibilities and mentoring peers 2012

Best outgoing student in the year 2012 from Manipal University in Msc Pharmacology

CERTIFICATES

Nov 2018: Signal detection and causality assessment (UMC)

Nov 2018: Statistical reasoning and algorithms in pharmacovigilance (UMC)

Nov 2018: Drug Safety and Monitoring Boards for Clinical Trials

Nov 2018: Introduction to Collecting and Reporting Adverse events in Clinical Research

Aug 2016: Serious Adverse Event Reporting: Information Session on Revisions to MEDDEV 2.7/3

April 2014: Good Clinical Practice for Clinical Trials



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