DR. PRIYATHULASI RAJKUMAR
PV Consultant, Project Management Coach and AI Enthusiast
Coimbatore
Summary
Experienced Life Sciences Consultant with 13+ years of expertise in providing Project Management, Quality Management, Consultation and Training services in Pharmacovigilance, including 5+ years of piloting and successfully implementing Artificial Intelligence models for Top Life science companies, and supplemented by 3+ years (2004-2008) in Clinical Practice. Successful track record of setting up Drug Safety / PV Units; identifying, developing & sustaining new Talent, Procedures and Processes. SME in pre and post marketing studies', having overseen end-to-end PV operations for: Merck, Nycomed/Takeda, Daichii, Fibrogen, Astellas, AstraZeneca and ~14 Trials.
Overview
20
20
years of professional experience
12
12
Certifications
Work History
Independent PV Consultant and Speaker
Forum Institut GmBH
02.2024 - Current
- Speaker, Forum Institut GmBH - on Artificial Intelligence in Pharmacovigilance and Project Management Seminars.
Senior PV Consultant
JSC Management und Technologieberatung AG
04.2022 - 09.2022
- In charge (Planning, Implementation, Finalisation) of global change and training management, for Arisg's LifeSphere Multivigilance (LSMV), for Merck (all users, including Employees, Clients and Vendors).
PV Consultant / Director of Project Management
ARC TRAICOA
09.2020 - 04.2022
- Introduced novel concept of ‘AGILE-PV' and adoption of Situational Project Management to facilitate PV processes in line with latest Project Management and Data Analytic methodologies.
- PV and Drug Safety - Procurement of Projects, setting up PV/DS business unit, CRM, End to End Training, Project, Quality and Operations Management, PV Consultation.
- Project Management - Training PV/IT project managers/aspirants on various global PM certifications like PMP, PMI-ACP, Scrum Master and Six Sigma Green Belt.
PV Consultant / Training Manager
Rang Technologies
11.2018 - 01.2019
- Facilitated end-to-end PV training, Arisg and Case Processing / Coding workshop and placement in CROs across USA for a batch of 6 US medical doctors.
PV Consultant / Project Manager
Navro Tech Solutions
08.2018 - 11.2018
- Piloted PV Artificial Intelligence project.
- Qualitative Signal detection from safety data (Annotated/tagged 6541 drug and 1360 vaccine posts, developing 14 PV & 6 vaccine vigilance safety insights respectively) from social media, medical journals, published articles, News feeds, etc. and created ML training data set upon which PV AI tool was built.
- Leveraged Deep Learning and NLP (natural language processing), along with Advanced Analytics and Folksonomy techniques for inventing Large Language Model for PV.
- SME for PV/Clinical data through domain expertise.
- Business process excellence and development solutions
- Project and Product Management.
Drug Safety Manager / Project Manager
ICON Clinical Research
Chennai
01.2008 - 01.2016
- Managed overall drug safety operations associated with entire adverse events case processing, including but not limited to safety data collected from Clinical trials, and Post Marketing studies (Literature, Spontaneous, HP cases etc.).
- Led teams of ~12-15 direct reports, undertaking Performance Reviews, Personal Development Planning, Performance Improvement planning (PIP), Absence Management, setting SMARTER goals, Resource Allocation and interviewing potential candidates.
- End-to-end PV Training and mentoring, by preparing detailed Training plan both for Fresher & Experienced DSAs and Project Management Training for Managers, including guidance on latest regulatory guidelines from EMA, FDA and ICH.
- Project manager, SME, SPOC, Process Improvement Lead and Root Cause Analyst for 2 major Clinical trial projects, one of them comprising 8 clinical trials. Awarded twice for excellence and commitment to work.
- Efficacy, Quality and Improvement lead for ArisG Safety Case Processing & Regulatory team for 14 Clinical trials.
- Preparation, Deployment, Validation and Change Management of QMS for MS Access literature surveillance tool. Final Quality in-charge (before client review) for Post-Marketing Services and Literature Surveillance projects.
- PV Compliance and Training (On Site-Germany): Focused solely on QA role by preparing SOPs, PSPs, conducting mock audits and, preparing regulatory reporting guidelines, and conducting trainings on narrative writing, SAE preparation and Query generation. Developed Compliance metrics tools and techniques, both project specific and for company procedures.
- Quality Assurance (In-house): Responsible for due diligence and ensuring anytime audit readiness for team by performing a regular check of all training records, PSPs and SOPs. Conducting regular mock audits with audit checklist, chairing audit meetings and preparation of audit reports. Faced 3 internal audits and 1 MHRA inspection.
- PV subject matter expert and top performer awardee for 3 yrs . consecutively, in quantity and quality of Literature articles reviewed & Cases processed (Triage, Data Entry, Narrative Writing, QC, Medical Assessment and Regulatory sub for cases from Literature, Clinical trials, Spontaneous, Other sources, in all versions of ARISG & ARGUS).
- Medical Writing - SOP, PSP, Trial/Study, Company procedures, Project documents and Job Aids. Certified PBRER writer.
- Medical Assessment for Non-Serious and Serious, Labelled cases and assistance to physicians for Serious, Unlabeled cases.
- Aggregate reporting and Signal Management activities from PRAC minutes and safety data provided by client.
- PSMF framing, writing support to physicians. Edited and managed content of Company's QPPV newsletter
Dentist
Various
03.2004 - 01.2008
- Communicated one-on-one with patients during consultative appointments to explain treatment plan and educate on upcoming procedures.
- Provided preventive care with regular checkups, educating patients on proper oral hygiene habits.
- Managed dental emergencies promptly, addressing acute pain and preventing further complications.
Education
Bachelor of Dental Surgery - Dentistry
Saveetha University
Chennai, India 04.2001 -
Master of Science - Clinical Research And Medical Writing
James Lind Institute
Coimbatore, India 04.2001 -
Bachelor of Arts - HIndi Language And Literature
Dakshin Bharat Hindi Prachar Sabha
Chennai, India 04.2001 -
Skills
Situational Project Management
Languages
English
Bilingual or Proficient (C2)
German
Upper intermediate (B2)
Hindi
Advanced (C1)
Tamil
Advanced (C1)
Telugu
Bilingual or Proficient (C2)
French
Beginner (A1)
Therapeutic Areas
- Vaccines, Immunology
- Oncology
- Neurology
- Cardiology
- Endocrinology
- Dentistry
- Hepatic disorders
- Dermatology
- Ophthalmology
Certification
Medical Transcription
Timeline
AI for Leaders (Various, LinkedIn Learning)
05-2024
Independent PV Consultant and Speaker
Forum Institut GmBH
02.2024 - Current
Senior PV Consultant
JSC Management und Technologieberatung AG
04.2022 - 09.2022
EU CEFR B2 in German Language
11-2020
PV Consultant / Director of Project Management
ARC TRAICOA
09.2020 - 04.2022
PMI ACP
06-2020
Dale Carnegie Master Trainer Certification
11-2019
EU CEFR C1 in English Language
10-2019
Professional Certificate on PBRERs Development, Writing and Submission for Medical Writers
06-2019
Scrum Certification
01-2019
PV Consultant / Training Manager
Rang Technologies
11.2018 - 01.2019
Vaccine Safety by WHO
11-2018
PV Consultant / Project Manager
Navro Tech Solutions
08.2018 - 11.2018
Six Sigma Green Belt
04-2018
Data Science and Analytics with R
02-2018
PMP
09-2017
Drug Safety Manager / Project Manager
ICON Clinical Research
01.2008 - 01.2016
Medical Transcription
11-2007
Dentist
Various
03.2004 - 01.2008
Bachelor of Dental Surgery - Dentistry
Saveetha University
04.2001 -
Master of Science - Clinical Research And Medical Writing
James Lind Institute
04.2001 -
Bachelor of Arts - HIndi Language And Literature
Dakshin Bharat Hindi Prachar Sabha
04.2001 -
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