Tushar Roy

*** ***** *****, **********, ** ***** 848-***-**** adg5i4@r.postjobfree.com www.linkedin.com/in/tushar-roy

With about three years of professional experience in Pharmacovigilance (PV) for Sun Pharma, Mallinckrodt, and Johnson & Johnson, I bring forward proficiency to perform effectively in a cross-functional industrial setting.

Educational Qualifications

Rutgers University, New Brunswick, New Jersey, U.S.A. August 2017- May 2019

MS, Microbiology, 3.722 GPA

D Y Patil University, Navi Mumbai, India June 2012- July 2016

MS and BS integrated, Biotechnology, 75.08% (academic top performance rank holder)

Work Experience

Sun Pharma (via Aerotek/Populas Group), New Jersey, U.S.A November 2019- Present

Drug Safety Associate

Submission of Aggregate safety reports i.e. Periodic Adverse Drug Experience Reports (PADERs) to the US FDA and CIOMS to Health Canada to maintain regulatory compliance.

Quality review of Adverse Drug Events (ADE) cases including clinical trial cases in ARGUS.

Management of Safety Data Exchange Agreements (SDEA) including preparation, negotiation, execution, maintenances of agreements, AE exchange, and reconciliations for the US and Canada teams.

Monitoring compliance of procedural and regulatory obligations, drafting deviations, and tracking Corrective and Preventive Actions (CAPAs) – provided support to Health Canada inspections and business partner audits.

Coordinating Standard Operating Procedures (SOPs), its revisions, and preparing training calendars for internal PV team and external vendors. Managing the implementation of the Learning Management system (LMS).

Oversight of the team’s performance by ensuring timely submission of Individual Case Safety Reports (ICSRs), helped streamlined follow-up activity and, cleared workflow through due diligence and metrics analysis.

Ad hoc report submissions including line listings to other cross-functional teams.

Management of PV systems – successfully ran multiple test scripts and developing systems for automation.

Successfully got three process improvements incorporated in the team to meet compliance and make work efficient. Areas improved: Case intake, reconciliation, data extraction, and follow-up activity.

Mallinckrodt Pharmaceuticals (via Populas Group), New Jersey, U.S.A June 2019- November 2019

Global Pharmacovigilance Scientist

Prepared aggregate reports i.e. E2C (R2) Periodic Benefit-Risk Evaluation Reports (PBRERs) and E2F Development Safety Update Reports (DSURs) using Veeva Platform.

oTasks included review of literature and integrating data from the clinical and regulatory team and its electronic documentation for submissions to regulatory authorities.

Prepared ad hoc FDA reports for a product under clinical trial based on DSMB request.

Assisted with core signal detection activities with Global Safety Lead / Medical director by reviewing safety data.

Co-chaired Annual Labeling Review meeting and other activities for label changes in a product as part of the Product Labeling Review Team (PLRT). Task included gathering safety data, generating data outputs, review relevant safety sections using CCDS, summarizing medically important events, and safety profile analysis.

As presenter of Product Labeling Committee (PLC) initiated proposals and discussions with other members including RA Operations and the company senior leadership team.

Driven Safety Management Team (SMT) and Global Benefit-Risk Board (GBRB) meeting and acted as a point of contact representative for safety with regulatory, clinical, legal departments, and vendors.

Mallinckrodt Pharmaceuticals, New Jersey, U.S.A January 2019- March 2019

Pharmacovigilance Intern

Preparation of an aggregate report PBRER and assisted in DSUR’s of other clinical products for IND applications.

CAPA and deviation filing and maintenance along with the development of SOPs, new work instructions (training initiatives), and support of process reviews and updates.

Updated PV System Master File (PSMF) and prepared model documents of PBRER/DSUR.

Practiced knowledge of Good Clinical Practices (GCPs) and ICH E2B guidelines.

Case processing activities including triage, case classifications (validity, seriousness, expectedness, etc.), MedDRA coding, causality assessment, writing, and editing the case narratives.

Managed clinical trial and post-marketing cases and ensured compliance with relevant regulations and processed other spontaneous and literature cases in ARGUS with good quality.

Johnson & Johnson (via Sciformix Technologies Pvt. Ltd.), Mumbai, India October 2016- July 2017

Drug Safety Data Analyst

Executed case processing activities, including ICSRs intake, triage of cases (EMEA, APAC, LATAM, and the US) based on seriousness criteria and reportability, performed duplicate searches, data entry of individual case reports into the RSS safety database.

oTasks also included MedDRA coding, causality, seriousness assessment, and writing case narratives.

Executed and took training initiatives during database transition (RSS to SCEPTRE).

Performed follow up, query management, and was involved in weekly contact with consumer contact center, managed outbound and inbound letters, and collaborated with the medical and quality team.

Received ‘Top performer’ certificate and ‘Sciformix Manager’s Admiration Reward for Talent’ three times for consistent productivity and quality of cases.

Publications

Microbial Pigments as Alternative Source for Bio-Colorants. Tushar Roy, Simran Lilwani, J R. Parvathi. RJLBPCS, 126-134, 2018. DOI 10.26479/2018.0406.40.

Effect of Homeopathic Preparation Calendula on Production of Phenols in Tylophora indica and Curcuma longa, Chaturvedi et al. Advance in Plant Sciences, 28(I) 115-119, 2015. ISSN O970-3586.

Academic Awards

Awarded with ‘Research that Inspires New Innovation’, Rutgers University, November 2017 STEM Community Outreach Symposium.

Awarded for ‘Innovative Technologies for Rural Development in Maharashtra’. October 2016

Received scholarship award several times for academic top performance June 2012- July 2016

merit holder, D Y Patil University.

Computer Skills

Working Knowledge of clinical safety databases: ARGUS, Remetrix Safety System (RSS), SCEPTRE, and Medical Inquiry Systems (MIQ).

Applications known: SharePoint, Veeva Platform, Microsoft Office [PowerPoint, MS Word, Excel], Adobe Creative Suite, and Learning Management Systems (LMS).

Computer language known: Basic PERL

Certified from MedDRA MSSO: Coding with MedDRA and Safety Data Analysis and SMQs.

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