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Inside Cliniminds


Our Pharmacovigilance Training
Partner
think-i

KEY PHARMACOVIGILANCE FACULTY MEMBERS

Dr. Anu Dambalkar, MBBS Senior Drug Safety Physician
  • Dr. Dambalkar comes with a good experience of over 7+ years in pharmacovigilance and clinical research with her Key competency skills in writing Periodic Benefit Risk Evaluation Reports (PBRERs)/ Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overview (ACOs), Health Hazard Evaluations (HHEs).
  • Dr. Dambalkar has good knowledge and experience in ascertaining the causality of Individual case safety report, checking for medical cohesiveness and expectedness of adverse events.
  • Dr. Dambalkar has good knowledge of Reference Safety Information documents, she is further well versed with safety regulations which includes
    • ICH guidelines on safety and efficacy
    • Volume 9a
    • FDA guidelines
    • CIOMS
Mr. Joseph Mathew Senior Manager- Pharmacovigilance Training and Consulting
  • Joseph comes with a varied experience in Pharmacovigilance & IT. He is a Subject matter Expert on Safety Databases and on writing White Papers, his recently published white paper was on Role of technology in Vaccine Safety. He is currently the Head of Pharmacovigilance operations at Think-i.
  • His Key responsibility areas includes Developing module on pharmacovigilance, Delivering end to end pharmacovigilance training and participating in business development activities and medical writing services.
  • Prior to his role in Think I, he was supporting Pharmacovigilance activities for Baxter Inc. by doing Intake of cases for APAC team which included reports from Taiwan, Korea, Vietnam, Hong Kong, Indonesia and India and regulatory submissions for Korea via KAERS (Korea Adverse Event Reporting System) by working closely with Local Pharmacovigilance officers of each country.
Dr. Subodh Bhardwaj Vice President Scientific & Medical Affairs
  • Dr. Bhardwaj is an innovative Medical Doctor with Post Graduation in Pharmacology and more than 30+ years of experience in Clinical Medicine, Clinical Research, Pharmaco-vigilance and Regulatory affairs.
  • He has varied experience of 20 years in the Bio- Pharmaceutical Industry with reputed companies like Serum Institute Of India, Sanofi Pasteur, Aventis, Shanta Biotechnics, Serono, MBL, Crucell and interactions with WHO, Ministry of Health, DCGI, DBT, ICMR, IMA, IAP, OPPI, APACHE, APCRI.
  • He has planned and completed over 100 clinical trials ranging from Pre-clinical, Phase1-4 and pharmaco-epidemiological studies. Possess exemplary skills in Regulatory affairs in India and fully updated on EU, US regulations.
  • He has worked in Pharmaco-vigilance domain in over 30 years with some interesting publications. He has excellent Medical writing skills and Editorial experience with Indian Journal of Pharmacology with over 60 publications in National &International Journals
Mr. V. Dalal Team Leader
  • Mr. Dalal is a certified Pharmacovigilance and Medical Writing professional, possessing more than 8 years’ of experience in authoring, review, team handling and project management of Pharmacovigilance aggregate reports, and review of scientific documents for regulatory affairs.
  • Mr. Dalal has authored as well as provided expert guidance in writing and review of complex scientific documents in par with global compliance with regulatory requirements. He has prepared standard operating procedures (SOPs), templates, and style guide of aggregate reports [Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER), Development Safety Update Report (DSUR), US Periodic Safety Report (PADER), and Annual Product Quality Review (APR-PQR) report].
G. Kumar Associate Team Manager Pharmacovigilance Operations
  • Mr. Kumar 7+ years of experience in pharmacovigilance operations. With managing team of drug safety staff to working with Medical Advisors/Medical Directors in preparation of project resourcing, Mr. Kumar is a Safety Processing Expert (SPE).
  • Mr. Kumar has an extensive experience in conducting Literature reviews, Reviews of PSUR, PBRER, PADER, line listings/summary tabulations, Preparing Signal Review Sheet for signal detection calculation and analysing the threshold, Writing case narratives , MedDRA coding.
  • Mr. Kumar has also participated in face to face MHRA inspection for ongoing project at PAREXEL International.
  • Apart from his experience in Pharmacovigilance, Mr. Kumar is also a Medical Writer, his job function enabled him assessing and analysing adverse drug reactions including paediatric analysis, for inclusion/update of the CCDS (sections 4.8 & 4.9)
Ms. M. Morusupalli Safety Associate
  • Ms. Morusupalli, a Post graduate in Pharmaceutical sciences comes, with a good experience in case processing of individual case safety reports.
  • Ms. Morusupalli has varied experience in carrying out Pharmacovigilance activities like literature searches, Preparation of deviation memo, Database searches, Registry and Triage of incoming cases to determine seriousness for prioritization of daily workflow, request translations as required (forward to LMD as appropriate) and Narrative writing for different trials.
Dr. J. Haq, Pharm.D Senior Associate
  • Dr. Haq is a subject matter expert on aggregate reports and an excellent corporate trainer. He has Drafted and reviewed various regulatory reports like Periodic adverse drug experience report (PADER), Periodic safety update report (PSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Addendum to Clinical Overview (ACO) and developmental safety update report (DSUR).
  • Dr. Haq was also part of the safety team for carrying out Literature searches through EMBASE and PUBMED, shortlisting and summarizing of new and significant citations pertaining to investigational product. His function also included preparation of summary reports through secondary research.
Mr. C. Kulkarni Manager Pharmacovigilance
  • Mr. Kulkarni is a result oriented professional with rigorous experience of over 9 years in the areas of Pharmacovigilance, Medical Information and Medical writing. He is presently spearheading as a Manager Pharmacovigilance in managing day-to-day PV activities.
  • Mr. Kulkarni has an excellent skill set in managing safety databases which includes implementation and validating documents (User requirement specifications, Software requirement specifications, Configuration Specification, Validation plan, OQ and PQ scripts, Validation protocols, Validation summary report and Traceability matrix)
  • Mr. Kulkarni has also served as the EU-QPPV Assistant for Hormosan Pharma GmbH
Mr. S. Jindal Senior Drug Safety Specialist
  • Mr. Jindal Meticulous and highly accomplished professional with extensive experience in Drug safety.
  • Mr. Jindal is currently the Global Trainer for training of literature process to worldwide Affiliates of the client and is acting as an Affiliate for local literature search. His core competency is in case processing of individual case safety reports including determining the expectedness of adverse events against labelling documents, writing case narratives and assessing causalities.
Dr. A. Mahajan, MD (Herbal Drug Medicine), MBA, CR-DS-PV Training Coordinator, Pharmacovigilance operations
  • Dr. Mahajan is seasoned Drug Safety professional with a varied and progressive 7 years of academic training and 3 year of professional hands on experience in Pharmacovigilance and drug safety case reporting (ICSR).
  • Dr. Mahajan has expertise in coordinating and implementing training related activities. He has comprehensive knowledge of ICH-GCP, E2B (R3), ICMR/ DCGI guidelines on GVP. EMA guidelines on GVP, Health Canada (Division5), USFDA/ CFR , ICH-(E&M), CIOMS,EMEA, US FDA, EduraLex (Vol.9/10), WHO(ICD10-CM/MedDRA-PT/SOC), Schedule-Y & ICMR guidelines. He possesses proven abilities to work effectively with internal and external stakeholders and to liaise with key opinion leaders.
Mr. N.B. Court Assistant Manager
  • Mr. Court has core experience in pharmacovigilance with working knowledge of all the regulatory classes from drugs till cosmetics. Mr. Court has experience in handling oncology projects undergoing clinical phases and responsible for all the pharmacovigilance activities for the projects. He was also the SPOC for medical monitoring team and data management team for pharmacovigilance activities for both the projects.
  • Mr. Court was also a part of the aggregate reporting team and has extensive experience in preparation of regulatory reports such as DSUR’s, PSUR’s, PADERS and PBRER. He also performed quality checks of Safety data exchange agreements by coordinating with the vendors for transmission of safety data.
Mr. H.K. Nyathani Safety Processing Expert
  • Mr. Nyathani is a dynamic seasoned professional with 8+ years of experience in drug safety. From having sound knowledge on product license configuration to integrate trade name and generic names to knowledge on SQL and PL/SQL in maintaining and tracking the Argus database Mr Nyathani is a problem solver and is of the capacity to develop solutions for the given tasks for supporting Safety database.
  • Mr. Nyathani is a study configuration Expert. He was a SPOC for the preparation of study guidance document (SGD) and Non interventional study (NIS) configurations in Argus console. He also has an experience as a review project Lead in providing trainings, assigning work to Vendors, tracking for timely completion and updating the status.
Mr. D.B. Bairagi Senior Global Safety and PV Associate
  • Mr. Bairagi is an experienced Pharmacovigilance (PV) professional with over 6+ years of experience. He has varied experience in Pharmacovigilance and clinical operations. He was involved in the review serious adverse experience (SAE) reports received from Investigator sites and adverse experiences (AEs) from post marketing sources.
  • Mr. Bairagi was also part of the Quality review team and was engaged in Performing quality control checks of completed individual safety reports to ensure compliance with regulatory reporting requirements
Ms. P. Gupta Manager Pharmacovigilance
  • Ms. Gupta is a seasoned subject matter expert on Pharmacovigilance with 9+ years of experience, she is currently Managing Pharmacovigilance operations for India.
  • She was Project Lead for clinical trial projects- set-up, project management, client liaison and represented Global Safety and Pharmacovigilance group at project team, client and Investigator meetings.
  • Ms. Gupta is also an excellent medical writer with her core competence in aggregate report writing DSUR, PSUR. PADER and has also Prepared and reviewed documents describing the process for monitoring and reporting serious adverse experiences e.g. SOPs, operating guides, Work instructions.
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