Leadership Team

Dr. Nisha Nair
Vice President, Pharmacovigilance

An experienced Pharmacovigilance professional with 7 years of experience who was associated with major multinational companies in the field of Pharmacovigilance . Her experience includes 3 years of team management and also handling ICSRs, medical writing , client delivery management , aggregate reporting , literature review , narrative writing , medical review and business development. She has led teams that consistently met and achieved targets and were always on the top of organizational charts for quality and compliance.

Dr. Namrata Tiwari
Consultant, Safety and Pharmacovigilance Operations , Training and compliance

She is associated with over 8 years in the pharmaceutical industry and worked in companies like Ranbaxy and Merck (MSD), where she was responsible for ICSRs, PSURs, SOPs, causality assessment, safety system validation and maintenance, ,Signal Detection ,safety database management, Safety Data Exchange Agreements, risk management plans and compliance monitoring. She also headed Pharmacovigilance operations thereby gaining experience in premarketing and post marketing safety reporting. Also fortunate to work on Eudravigilance project and was EMEA accreditated QC trained for ICSR.

In Thinki, she heads the Pharmacovigilance Unit, playing a key decisive role in establishing the unit and guiding team members for successful inspections by clients and regulatory authorities. She is responsible for global quality and compliance.

Dr. Raj Phadtare
Drug Safety Consultant

  • Experienced Drug Safety professional with over 12 years of experienceat various levels in small to mid-sized Bio-pharmaceutical companies in the USA
  • Responsible for all Pharmacovigilance activities for marketed and investigational drug products
  • Authored and ensured that individual SUSAR reports and aggregate safety reports (PSURs,DSURs) for FDA and EU regulatory authorities were completed and submitted in accordance with regulatory requirements
  • Worked on a CCSIs of marketed products
  • Reviewed Protocols and Investigator Brochures
  • Chaired the Medical Safety Review committee which is established to monitor the safety of the products in clinical development and/or in the Market. Activities include but are not limited to identification of potential product specific safety signals/trends, AE case series review, review of scientific literature, review and updates to product labels
  • Created and maintained Pharmacovigilance and Safety Data Exchange Agreements; served as company/partner liaison; ensured corporate and partner compliance with internal and global regulatory requirements
  • Participated in the development of and provided oversight for the REMS program for a CNS product
  • Participated in successful FDA audits for Pharmacovigilance
  • Developed SOPs and Work Practice guidelines for Drug Safety department throughout the life cycle of the product (pre and post marketing) and centralized Drug Safety functions at various companies
  • Responsible for handling safety related activities including receipt, triage, processing, reporting and dissemination of Adverse Events and Serious Adverse Events (SAE) from spontaneous sources and SAE’s from company sponsored clinical trials
  • Supported case processing activities by performing medical review of the cases and assessing the expedited reporting
  • Managed the activities of Drug Safety vendor for AE case processing

Mr. Pinku Hooda
Head, Clinical Data Management

A high-performing operations-management executive with expertise in all aspects of Clinical Data Management and SAS for Phase I to IV and BA/BE studies for a wide array of therapeutic areas, Mr. Hooda has over 10 years of experience working in pharmaceutical companies and CROs with a strong commitment to this important field of research. He can effectively interface and collaborate between Data Management, Biostatistics and Pharmacovigilance teams to ensure high quality data and on-time completion of complex, large-scale projects. His chief expertise lies in leading and training project teams as he possesses strong communication, interpersonal, problem solving, planning, and organizing skills.

Ms. Sapna Sharma
Head, Training and Clinical Research Operations

Ms. Sapna Sharma is a clinical Research Professional with 8 yrs of progressive experience (both national and International) working in Pharmaceutical and Contract Research Organization industry. She possesses excellent interpersonal and communication skills along with clarity of fundamentals with perseverance to succeed and zeal to achieve results; excellent team management skills, acquired by working with teams in different parts of the world - APAC (South Korea, Thailand, Vietnam, China, India Philippines, and Indonesia) and EU (United Kingdom, Israel, Poland, Spain, Bulgaria and Hungary).

She also has a broad background in clinical trial management of phase I/ II/ III/ IV drug and device trials, in various indications including the site monitoring and on-site data management and collection. Specialized in patient recruitment activities in India and other APAC countries, meeting client expectations on projects has always been priority agenda of her work during these last years.

She brings with her good medical writing skills with publication of Journals, and research papers, along with a book on Clinical Research (under development) and is also an expert in writing protocols and other clinical research related documents.

Dr. Subodh Bhardwaj
Vice President Scientific & Medical Affairs

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. 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.

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. Have worked in Pharmaco-vigilance since 30 years with some interesting publications. Excellent Medical writing skills and Editorial experience with Indian Journal of Pharmacology. Over 60 publications in National &International Journals. Have actively published several product monographs, PILs and publications for public interest. Have been MPharm & Phd guide at University of Pune. Excellent Public speaking and Analytical skills. Widely travelled and have done clinical trials in 10 countries across the world. Proven track record in the health sciences field.

Dr. Sanjukta Bhattacharya
Clinical Research & Medical Writing Expert

PhD is a pharma professional with 14 years of industry experience including 9 years in clinical research and 5 years in project management of NCE preclinical & clinical development. She is skilled in conducting ICH-GCP and Schedule Y of Indian Drugs and Cosmetics Act governing clinical trials. She has extensive experience in managing multicentric trials across India, Asian and African countries. She has worked in Ranbaxy Research Laboratories, Pharmacia (Pfizer) and LG Life Sciences in multicultural environment.

She has also been a visiting faculty at Jamia Hamdard University, Delhi where she has taken lectures for post-graduate students of clinical research.

At Ranbaxy, she lead the clinical development of Synriam, an antimalarial – India’s first new drug which was launched in 2012. She has received various awards for demonstrating commitment and contribution in clinical research. She was recently felicitated by the former President of India, Dr. A.P.J. Kalam for exceptional contribution in development of Synriam.

DR A. PANDEY
PHARMACOVIGILANCE EXPERT

Dr. Pandey is qualified medical doctor with 11 years of experience in managing Healthcare, Life sciences, Pharmacovigilance process transition, operations, client interaction.

Dr. Pandey has extensive experience with Accenture as Deputy Manager and iGATE as Team Manager – Pharmacovigilance Operations. Worked as Domain expert/ SME –pharmacovigilance with Pfizer Inc. Her experience and skills includes :

  • Expertise in handling client facing situations.
  • Strong Project management and operations management skills.
  • Strong knowledge in maintaining quality systems to ensure the quality of processes and deliverables of both projects and services meet the expectations as per regulatory requirements.
  • Validation lead for multiple projects.
  • Argus implementation boot camp training conducted by Oracle.
  • Trained in Argus 7.0 safety application.
  • Knowledgeable in processes and tools pertaining to Pharmacovigilance (Argus, ArisG, Ag Exchange and CARES) based on COTS life cycle.
  • Knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Code of Federal Regulations, Volume 9A etc.
  • Business Process development - Developed SOPs and SOW for the process.
  • Functional testing (OQ/PQ) for ArisG safety suite.
  • Post execution QA lead for testing of PQ/OQ scripts of ArisG safety application and Ag Exchange suite.
  • Extensive exposure in managing drug safety operations in leading IT companies.
  • An effective communicator & competent subject matter expert with honed analytical, operational & organizational abilities.
FOLLOW
Google+ Blog