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Drug Safety, Argus 8.0, MedDRA 19.0, GVP, GCP, CIOMS V, Oncology cases

Location:
Boston, Massachusetts, United States
Posted:
February 07, 2018

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Resume:

Dr Apoorva Anil Joshi

ac4dvr@r.postjobfree.com https://www.linkedin.com/in/dr-apoorvajoshi 857-***-**** 1167 Boylston street, Boston, MA. CORE COMPETENCIES AND SKILLS

ICH-GCP, GLP, GMP, NDA, IND, 510(k), IDE

Premarket Approval, IVD, HUD, GVP

Literature review (oncology and non-oncology)

Clinical trial cases, E2B cases

Argus 6.0 and 8.0

MedDRA 19.0 and WhoDD

Pharmacovigilance physician

MS excel, MS word, MS powerpoint

Peer training and quality review

Medical review and drug safety.

SUMMARY

A drug safety physician, MBBS degree holder (International MD equivalent) with 2.5 years of experience in pharmacovigilance sector assessing the risk benefit profile of pharmaceutical products by analysing ICRS, Labeling documents with the help of a safety database.

EDUCATION

Northeastern University Boston, MA

Masters Of Science in Regulatory Affairs- Exp Apr-2019 Drugs, Biologics and Medical Devices (GPA 3.83/4)

Relevant Course Work: New Drug Development, Biologics Development, Medical Device Development. MGM Institute of Health Sciences Mumbai, India

Bachelor of Medicine and Bachelor of Surgery. (GPA 3.00/4) Aug-2008 to May-2014 PROFESSIONAL EXPERIENCE

Cognizant Technology Solutions Mumbai, India

Drug Safety Physician Feb-2015 to Jun-2017

Pharmacovigilance:

• Performed pharmacovigilance activities for various case report forms with expertise on oncology, non- oncology, post marketing, literature, clinical trial, SUSAR, market research, partner cases, LOC cases, spontaneous cases, E2B, social media cases as per the regulatory timelines with 100% complaince.

• Acquired expertise in MedDRA in accordance with “MedDRA Term Selection: Points to Consider” and WHODD.

• Determined the medical cohesiveness of the narrative and reconstructed over 5000 narratives as per the reference documents.

• Accurately verified the seriousness of the cases based on the six seriousness criteria, IME (Important Medical Events) list, CTCAE grading and medical knowledge.

• Verified the accuracy of expectedness/listedness/ of the events as per the labelling documents (IB, CCDS, USPI, SmPC, etc) and the causality/relatedness of the events.

• Actively involved in triaging of cases, duplicate searches using safety database, case prioritization and follow-up activities with third parties as per the seriousness and regulatory timelines. Client meetings and Peer training:

• Advised and supervised the drug safety associates’ daily pharmacovigilance activities and conducted trainings refresher trainings regarding the updated labelling documents, new types of case reports, regulatory compliance criteria, seriousness criteria assessment and updated key event list.

• Conducted product specific training of peer drug safety physicians.

• Participated in one to one client meetings and discussed the upcoming issues related to case processing and medical reviewing.

Extracurricular/co-curricular activities: Dec-2016, May-2017

• Hosted a Rewards and Recognition function for the entire off shore development unit of the company in Mumbai comprising of case processors, quality reviewers, team leads, managers, directors, global safety leads from different countries from the client site. ACADEMIC PROJECTS

MGM Institute of Health Sciences Mumbai, India

Internship March-2013 to May-2014

• Acquired hands on experience and expertise in differential diagnosis and patient care while working as an intern in various departments like general medicine including psychiatry, general surgery including anaesthesia, orthopaedics, paediatrics, otorhinolaryngology, ophthalmology, obstetrics and gynaecology, radiology, dermatology and emergency medicine.

• Actively participated in rural medical camps as a community medicine intern. Ensured primary health care in urban and rural health centres.

College Of Professional Studies, Northeastern University Boston, MA Regulatory Submission July-2017

• White Paper Submission (Drugs)- Overview of the nonclinical pharmacology and toxicology studies of Kalydeco, The risk management plan and approval strategy of Lemtrada, An overview of Good Laborator Practices, Good Manufacturing Practices and Good Clinical Practice, Pediatric Deferral Equity Act waiver and deferral request letter, Pre-IND Meeting Request Letter, Regulatory Development Plan of vedolizumab

• White Paper Submission (Medical Devices)- Regulatory pathway of Augment Bone Graft System, Boston, MA

September-2017

• White Paper Submission (Medical Devices)- Reclassification of the Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis and the Knee Joint Femorotibial (Uni-compartmental) Metal/Polymer Porous-Coated Uncemented Prosthesis,

• White Paper Submission (Biologics) Regulatory Milestones of a Fibrin sealant, Pre-clinical plan for use of B-cell therapy in treatment of cancer based on an approved patent, Strategized and constructed a clinical trial synopsis and a regulatory strategy document based on the pre-clinical plan of B-cell therapy.



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