Data Entry Pharmacovigilance Scientist

Bhagyashree Gosar

Boston, MA

+1-314-***-**** *****.*@************.***

linkedin.com/in/bhagyashree-gosar-63246663

EDUCATION

NORTHEASTERN UNIVERSITY Boston, MA

Master of Science in Regulatory Affairs Expected December 2022 GPA:3.9/4.0

Academic Projects

• Prepared eCTD document for submission activities for a drug-device combination approval from regulatory authorities such as IND/IDE, PMA, PMA supplements, annual reports etc.

• Knowledge about FDA regulations, pre-clinical and clinical requirements, IND submissions and meetings with FDA, cGMP requirements, FDA MedWatch programs.

• Gained knowledge on how to review product labelling for compliance with global labelling regulations.

• Knowledge about NDA and BLA requirements for drug and biological products and different division of FDA such as CDER, CBER, CDRH etc.

• Can assist in preparation, submission, and maintenance of product specific dossier (eCTD) as per regulatory requirements such as FDA, EMA and any country specific requirement.

• Prepared a Regulatory strategy for commercialization of Magic Dust include details on clinical development plan (CDP), Risk- Benefit analysis, Clinical Trial Design Selection, NDA, Pricing and reimbursement, IPR and Post Market surveillance Plan.

• Can assist in development, maintenance and implementation of regulatory strategy procedures and SOPs.

• Aware about promotional and advertising literature for compliance with applicable regulations.

• Familiarity with several additional regulatory resources (e.g., Federal Register, ClinicalTrials.gov, Daily Med, *****@***.***) obtained through completion of assignment involved critical application of course material towards developing solutions in real world situations.

• Presented a presentation on Periodic Benifit-Risk Evaluation Report on Inbrija during course and gained knowledge about ICH E2C (R2), ICH E2F, M3R2, FDA adverse event reporting systems, VAERS etc.

• Overview of writing submission documentation for 510(k), PMA, NDA’s, Investigational Device Exemptions applications and Technical Files updates.

• Develop European Medical Device Regulation (EU MDR) Technical Files for a variety of products and perform gap assessments on existing Technical Files/Design Dossiers, Clinical Evaluation Reports and Labeling against Medical Device Reporting requirements

MUMBAI UNIVERSITY Mumbai, India

Bachelor’s in pharmacy June 2013

GPA:3.6/4.0

PROFESSIONAL SUMMARY

• Holding approximately 7 years of experience with processing Individual Case Safety Reports (ICSR) for marketed and investigational products from all sources. Carry out all relevant case processing activities throughout lifecycle of ICSR. Manage assigned ICSR workflow to ensure that all case processing activities from receipt through regulatory submission are carried out in accordance with relevant regulatory requirements and established company processes. Handling queries via action items, reconciliation activities, medDRA handling, experience in databases like Argus, Aris-g, aware, Agxchange. Mentoring and training activities, involved in risk management plan and signal detection. Involved in writing RCA CAPA and evaluation of KPI.

• As a highly motivated professional, and my prime objective is to join a progressive company that is seeking industrious individual to fill a challenging position in Regulatory affairs or related areas as a Post Market Surveillance, or Compliance Specialist. I have in depth knowledge about IND and NDA/BLA submissions, 510 (k) pathway, ICH-GCP requirements, cGMP requirements, Clinical development plan.

• Works well with cross-functional teams to minimize the regulatory risks.

• Offering excellent communication and good judgement.

• Willingness to take on added responsibilities to meet team goals.

• Dedicated pharmaceutical professional with history of meeting company goals utilizing consistent and organized practices.

• Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand.

• Specialities: Pharmacovigilance activities (GVP Module V), PSUR, DSUR, PBRER preparation, National and international regulatory compliance (FDA, EMA etc), assemble documents for eCTD, Assessment of RCA. WORK EXPERIENCE

Sen-Jam Pharmaceutical (Capstone Project) Boston, MA Designation: Regulatory affairs Intern Sep-22- Dec-22

• Preparation of IND for the submission of Emergency use authorization (EUA) for Covid-19 Product

• Preparation of market segmentation for covid-19 product based on company's mission

• Preparation for regulatory requirements for the APAC region

• Coordinate the submission of US IND amendment for updated CMC information Lyndra Therapeutics Boston, MA

Designation: Quality and Regulatory Co-Op Jan-22- Jun-22

• Collaborate with manufacturing department to monitor processes, and controls, ensuring that performance and quality of products are met the standards and agency guidelines (21 CFR 211, 21 CFR 210).

• Assisted with continuous improvement by providing quality feedback on GxP.

• Assisted in technical review of manufacturing batch records

• Assisted in creating SOP on quality events to ensure all deviations are recorded routinely.

• Responsible for qualifying GMP suppliers according to Supplier Quality Management and evaluate all external vendors for GMP, TSE/BSE, melamine free etc certificate.

• Helped in implementation of eQMS from paper based, designing of eQMS.

• Participated in User Acceptance Testing (UAT) activities ranging from reviewing test scripts to conducting dry runs and formal execution testing.

• Assisted with the development of global regulatory CMC strategies for investigational.

• Assisted in regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations

• Performs all necessary administrative duties as assigned including preparation of documents for approval and filing of IND application.

• Support Regulatory Lead in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)

COGNIZANT TECHNOLOGY SOLUTIONS (CLIENT: SANOFI PHARMA) Mumbai, India Designation: Drug Safety SME/Acting Team Lead

Software: Argus v8.0 July 2018 - February 2020

• Responsible for processing of all Serious Adverse Events (SAEs)/Expected Adverse Events (EAEs) transmitted to the Argus safety database.

• Perform Quality control checks of SAE/EAE reports, triages for completion and accuracy, and reviews source documentation.

• Functioned as a team lead or primary point of contact for all drug safety case processing issues related to a specific range of Sanofi-Genzyme products.

• Performed safety trend analysis on assigned products for submission to the FDA.

• Provided post marketing safety analysis and input for various submission dossiers including safety input for CTD modules 2.7.4, 2.5 and 5.3.6

• Provided post-marketing safety input for NDA submissions and IND submissions.

• Prepared and revised safety narratives for IND and Non-IND SAEs

• Consulted with regulatory representatives to manage filings, applications and reports.

• Expertise in clinical protocols and submission components such s summary of clinical safety and summary of clinical efficacy.

• Trained new hires in regulatory policies or procedures, kept up to date with changes in regulatory legislation and guidelines offering advice about company policies, practices and systems. PROCESS IMPROVEMENT

• Assisted in the development of case processing and safety surveillance processes and writing corresponding SOPs

• Co-develop data entry process instructions and update accordingly when processes and procedures change

• Co-develop follow-up processes (letters, questionnaires and phone contact) to obtain relevant medical information pertinent to case analysis and signal detection

TATA CONSULTANCY SERVICES (CLIENT: ROCHE PHARMA) Mumbai, India Designation: Pharmacovigilance Scientist

Software: Aris-g v9.0 October 2013 - June 2018

• Completed data entry of individual case safety reports (ICSRs) from clinical trials and post marketing sources utilizing Aris- g. Also performs active follow-up on ICSRs.

• Conduct complete clinical reviews of all adverse event reports for all Roche/Genentech investigational and marketed products

• Ensured consistency in the evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility and ensured compliance with the Safety Data Exchange Agreement (SDEA) was fulfilled

• Exercised judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listedness and reporting requirements

• Responsible for the initial assessment of causality and reportability of an SAE report.

• Ensured accuracy of coding which includes selecting appropriate event terms in MedDRA.

• Collaborated with partnered CROs and Regulatory Affairs department to collect, compile, and check the compliance percentage of previous Safety Reports submissions to the regulatory authorities

• Assisted in the preparation of NDA Safety Updates, IND safety reports, investigator communications, and other reports as necessary.

• Lead trainer for workflow process in Argus Safety Databases for new hires.

• Improved the SAE reconciliation process to be more efficient. Coordinated with Data Management personnel to reconcile key data fields between the Safety Database and the Clinical database; assisted in rectifying any discrepancies.

• Determined critical queries for missing, discrepant, or additional source document needed for safety reports.

• Assisted in the creation or revision of Drug Safety SOPs and Work Instructions.

• Served as Subject matter expert during regulatory inspections, business partner audits and quality investigations.

• Handled Quality reviewer’s position and performed quality check of ICSR

• In depth knowledge of national/regional regulatory legislation and guidelines. SKILLS

• Regulatory Compliance (COC and COA)

• Technical File Management (DMF/DHF/TD)

• Policy and procedure development (SOP, Guidance document)

• Quality review and analytical thinking

• Labelling drug products

• QMS/QSR and CAPA implementation

• Authoring PSUR’s/DSUR’s and PADER’s

• USFDA/EU/EMA/ICH guidelines

• Literature search and analysis

• Medical tools- Aris-g/Argus/ MedDRa/ EPIC

• Knowledge about IND/NDA/ANDA/Ectd

• RMP, REMS, EUMDR, 21CFRs, EHS

• ISO 13485, 14155/510(K)/PMA

• Salesforce doc, control/e-submitter/WebTrader/Agile/VEEVA/Ensure/Trackwise/mono Ectd

• Microsoft Office (Word, PowerPoint, Excel)

EXECUTIVE ACHIEVEMENTS AND HIGHLIGHTS

• Received Lion award from the client for preparing narrative template which helped in tremendous reduction in the error.

• Received star performer award for performing meeting all SLA in production and quality.

• Won Unicorn Award for best technical trainer and adhering to all SOPs and SLA.

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