We are a professional team of pharmacovigilance professionals with a wide range of skills and experience. We love what we do, and we do it with passion. We look forward to working with you.
Pharmacovigilance Associate at Indian Pharmacopoeia Commission having more than 10 years of experience in Pharmaceutical companies, CROs and Pharmacovigilance. He has published a book as author and many articles into his credit. He had started his professional career as officer Quality Assurance in Akums Haridwar then moved to Ciron Drugs, Mumbai. He had worked for Ipca Laboratories Ltd at Silvassa, DNH. Currently he is working for Indian Pharmacopoeia Commission. He is a certified ACRP member, USA.
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Manoj Kumar Maharana
Ex Army Professional having 30 years of experience in Army Medical Colleges. He had got posted at Lucknow, Pune, Ambala, Kolkata during his service career. He had got retired from Head Clerk position and having excellent knowledge in communicating letters and maintaining records.
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Arts teacher having 3 years of experience as social worker. She owns a medical store in Koraput district of Odisha and have a good experience in dispensing drugs and maintaining financial records.
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Dr. Rabinarayan Acharya
Chief Advisor (India)
Vaidya Rabinarayan Acharya, is a professor of Dravyaguna at ITRA, Jamnagar, where he has been a faculty since 2007 and currently working as HOD Dravyaguna and Dean. He has completed PG in 1996 , Ph.D. in 2002, from Gujarat Ayurveda University. He is having more than 26 years of teaching experience, more than 300 research articles in peer reviewed journals and authored five books. Prof. Acharya currently providing services to the Ministry of AYUSH, Govt. of India at different capacities such as Chairman APC, member ASUDTAB, member scientific Advisory Group for drug development CCRAS, Project Screeing committee of NMPB, Co ordinator IPvC.
Dr. Rajinder K Jalali
Founder Chief Scientific Advisor
Dr. Rajinder K Jalali is having more than 30 years of experience in Pharmaceutical Industry, Patient Care and Academic Institution Currently working as Healthcare Consultant Drug Safety, Clinical Research & Development and Medical Affairs; Member of Pharmacovigilance Commission of India (PvPI); Member Governing Council Sun Pharma Science Foundation & Sun Pharma Healthcare Society, Chairman Saanvi Ethics Committee; and Capacity building for healthcare professionals and pharmaceutical Industry. Formerly Global Head Pharmacovigilance and Head Medical Affairs & Clinical Research Sun Pharmaceutical Ltd. Formerly Adjunct Prof. in Center for Transitional and Clinical Research, Jamia Hamdard University, Delhi. Authored several Book Chapters in “Pharmaceutical Medicine & Translational Clinical Research, an Elsevier Publication 2018” covering various topics in Pharmacovigilance: Clinical & Post Approval. Safety Data Management ; Individual Case Safety Reports; Development and Periodic Safety Reports; Risk Management in Pharmacovigilance ; Generic Drugs and Bio-equivalence Studies.
Dr. Maya Sharma
M.D. Physician with 17 years of diversified experience across healthcare spectrum – clinical / pharmaceutical / nutrition / medical devices. Currently associated with Umesh Modi Grp. of companies (Modi-Mundipharma, Win Medicare, Signutra Inc.) as Global Medical Director. Chosen as Executive Board Member, ACMA Asia and Advisory Board Member, Journal of Pharmacovigilance and Drug Research. Brings an experience mixed of Multinational and Indian majors, established businesses and start-ups: AstraZeneca, Abbott, Philips, Signutra. Successfully handled diverse portfolios: Cardiology, Oncology, Diabetes, Medical Devices, Nutrition and has significant experience in Medical Affairs Leadership, Regulatory, Pharmacovigilance, KOL engagement, Compliance, Brand management, MSL/regional medical role, Business Development, domestic and International pre-launch and launch activation. Invited as a guest speaker/panellist on Aaj Tak (Indian TV News channel), Disruption Moments (Europe), Youth Transformation (UK), Lovely Professional University, Goa Institute of Management, Kalyani University, Global Medical Affairs Conference, Pharmacovigilance conference by Indian Pharmacopeia Commission, International PVG Conference, International Medical Affairs Leadership and various Nutrition Conferences and Seminars.
Dr. Avinash Kakade
Founder Member (India)
Dr Avinash Kakade is currently SGM, Global Head of Pharmacovigilance at Lupin Limited. He is responsible for global pharmacovigilance and medical information activities at Lupin. Prior to Lupin, he was in a similar role at Cipla Limited. Being a Medical Doctor, he practiced for 6 years in community and hospitals before starting his career in the pharmaceutical industry. He has worked with Wockhardt, Sciformix, Aspen, Accenture and Amgen in the past. He is a certified PMP from PMI and has Lean Six Sigma Black Belt certification along with a Masters in Biostatistics. He loves cooking which acts as a stress buster for him. He conducts informal mentoring sessions on LinkedIn and is also associated with a journal of pharmacovigilance and drug research in a pro bono advisory member role.
Dr. Neha Vala
President (West Zone India)
Dr. Neha Vala, is MBBS doctor, with total of 16 years of experience including 2 years of clinical hospital experience and 14 years of experience in clinical research and pharmacovigilance. Well versed with basic pharmacology, clinical pharmacology, good clinical practices, global guidelines on pharmacovigilance practices and MedDRA. Expertise in risk management planning, signal management, benefit risk evaluation and pharmacovigilance of clinical trials. Experience in handling various global regulatory inspections and audits. Have faced more than 20 regulatory inspections. Acted as speaker for various national and international pharmacovigilance conferences. Currently working with Emcure pharmaceuticals Limited as Global Pharmacovigilance Head and Pharmacovigilance officer-In-charge for Emcure products marketed in India. Also acting as advisory board member of Journal of Pharmacovigilance and Drug Research.
Dr. Y. Roja Ramani
President (East Zone India)Co-ordinator, Medical Education Unit, MKCG MCH, Berhampur
Co-ordinator, Adverse Drug Reaction Monitoring Centre, MKCG MCH, Berhampur. Curriculum committee member, MKCG MCH, Berhampur. Treasurer, Annual Conferences IPS- OSB [Two times]. Executive Body Member of IPS-OSB [four times]. Quiz Master, Indian Pharmacologicl Society-Odisha State Branch. Editor of News Letter: Rational Therapeutics – An Official Publication of IPS-OSB. Member Secretary, Institutional Ethics Committee[IEC], SLN MCH Koraput [2017-2018]. Associate Editor, Research Journal of Pharmacy and Life Sciences
Dr. Pratibha Nadig
President (South Zone India)
Dr. Pratibha Nadig is M.D. in pharmacology. Currently the Professor and head of pharmacovigilance at Vydehi Institute of medical sciences and research centre. She is the co-ordinator for Adverse drug reaction monitoring centre under pharmacovigilance program of India. She has been the Head at R & D centre, Natural remedies, Institute of clinical research ( India) and at Vydehi Institute of medical sciences and research centre. She has guided undergraduates, postgraduates and Phds in pharmacology and pharmacovigilance. She has several national and international publications to her credit.
Dr. Josue Bautista Arteaga
Founder Chairman (Americas Region)
Pharmaceutical Chemist with 15 years of experience in the pharmaceutical sector. He holds a degree in Pharmaceutical Administration. President of the Mexican Pharmacovigilance Association. Since 2006, he has played several roles across the Pharmaceutical Industry in areas such as: Quality Control, Quality Assurance and Medical Information, but since 2011 he has been working in Pharmacovigilance for Wyeth, GlaxoSmithKline and Merck Sharp & Dohme and Pfizer, on his recent role he was responsible of the PV operations for the AMER region ( CAN, USA and LATAM) as Senior Director.
Dr. Cinthya Galicia Quintanar
Founder Chairperson (Mexico)
Cinthya has over 10 years of experience in Pharmacovigilance Regulation; is a Fellow of Pharmacovigilance Mexican Association and serve as Vice-President on the executive committee. She holds a Degree in Pharmaceutical Biology Chemist from Universidad Nacional Autónoma de México [National Autonomous University of Mexico ] and a Master in Health Sciences from Higher School of Medicine of Instituto Politécnico Nacional [National Polytechnic Institute] and has taken courses and certifications on Risk Management Plans, Signal Detections, Clinical Pharmacology among others. Cinthya previously served as Safety Responsible for companies as Medix, GlaxoSmithKline, Stendhal and AstraZeneca where she has the opportunity to lead activities for Mexico and LATAM region and currently serves as Sr. Manager Country Safety Lead for Pfizer Mexico.
Dr. Luca Cariolato
Founder Chairman (Switzerland)
Dr. Luca, after obtained his master in pharmaceutical biotechnology in 2004 and Ph.D. in Life Sciences in 2011, he started his career in in Pharmacovigilance in 2013, as consultant. For more than 8 years, he was involved in medical writing, in particular in signal assessment reports; aggregate reports benefit-risk assessments and updates of product information. his main goal is to build a robust safety surveillance process that provides a robust company position to assure the safety of the patients and the evaluation of the benefit risk of the products during the entire lifecycle of a product.
Mr. Alain Kut
Founder Chairman (France)
He is Graduated in MSC, is having 20 years of experience in the field of pharmacovigilance. He had started his journey in Pharmacovigilance from Pfizer in 2001 and had worked for many pharmaceutical industries like GlaxoSmithKline, Servier Laboratory, Sanofi-Aventis, Celgene corporation, Biogen Idec, Anticip Sante, Guerbet, Stallergenes, Teva, Omega Pharma Belgium and as pharmacovigilance consultant for Besins, Merck, Eisai, HRA Pharma, Pfizer. He is having tremendous knowledge in EMA GVP modules: Edudravigilance, QMS in PV, QA, ICH Q8, Q9, Q10, Signal detection and safety reports writing and Regulatory Affairs/labeling (creation and updating CCDS according to ICH WG III and V), (SmPC, PIL, Packagine according to QRD template V.10.1
Maria de Penha Silva
Founder Chairperson (Brazil)
Graduated in Pharmaceutical Sciences with Post-Graduation in Pharmaceutical Marketing, Master of Business Administration -MBA in Project Management and ongoing Master’s in Epidemiology by Institute of Tropical Medicine – University of São Paulo – USP. Experience of 20 years in product surveillance (Pharmacovigilance, Technovigilance and Cosmetovigilance) in multinational, national and CRO companies. Experience in vaccines, biologicals, and synthetic drugs surveillance. Responsible for the implementation of the Pharmacovigilance Department and Quality Management System ISO 9001: 2000 in pharmacovigilance area at local level. Project manager with 5 years of experience in conducting and managing local and regional projects in product surveillance area with implementation of Case Management Hub in Pharma Company in Brazil in 2018 and Cosmetovigilance System in Cosmetic Company in 5 Latin American countries in 2011. Recently act as local safety officer in Alexion Brazil where is responsible for Pharmacovigilance System in rare diseases.
Dr. Ahmed Hegazy
Founder Chairman (Dubai, UAE)
Dr. Ahmed Hegazy is a Physician by education and holds a Master’s degree in Pharmaceutical Medicine (First Class Honor), Mini MBA, Medical Quality Management Diploma and Hospital Management Diploma. He owns more than 24 years of wealthy experience in Pfizer and Merck in different regions and functions (sales, training, medical, marketing and PV). He is an Expert in the Medical Affairs as he worked for 11 years in various positions in the Medical Affairs (Sr. Manager, Regional Manager and Head) in which he got experience in all MA roles, clinical research, governance, compliance, quality. He possess strong medical knowledge in various therapeutic areas and many products’ portfolios. Currently, he conducts medical development programs. He was holding a position of Head of Global Patient Safety for Africa, Middle East, Turkey, Russia & CIS countries (82 countries) for 7 years in Merck in which he was managing more than 16 subordinates based in 8 different countries.
Founder Chairperson (Argentina)
Agustina Zilifian has a Bachelor’s degree in Nutrition from the Barceló University of Medicine, counting with clinical experience and 6 years of involvement in different areas of the pharmaceutical industry, exercising roles in the pharmacovigilance area since 2014. Currently acting as the local Pharmacovigilance manager for Argentina, Paraguay and Uruguay at Boehringer Ingelheim, having worked in the past for Sanofi and Cognizant Argentina. Additional studies include Monitoring Clinical Research Programs, Pharmaceutical Marketing and Social Intrapreneurship.
Dr. Mohammed Shoeb
Founder Chairman (Germany)
Dr. Mohammed Shoeb holds a Doctor of Human Medicine (MD) degree from Aleppo University and certified as an Internal Medicine Physician from the Saudi Commission for Health Specialities. He is currently working at Dr. Haney Pharma GmbH in Wackerow, Germany as an EU QPPV and Pharmacovigilance Auditor for the last 5 years. He has over 20 years of experience as an Internal Medicine Physician having worked at Almana General Hospital and Qatif Central Hospital in Saudi Arabia.
Dinath Emireth González Riverón
Founder Member (Mexico)
B. Ch. – Graduated with honorable mention from the Food Chemistry career by the Faculty of Chemistry of the UNAM, a mention she received for her bibliographic work on “Professional experience in the Pharmacovigilance Unit (PV) in the Pharmaceutical Industry”. – Extensive experience in Pharmacovigilance (PV) and Technovigilance (TV) area in coordinator positions, leader of the area at LATAM level, and senior specialist in companies such as AstraZeneca, Apotex, and GlaxoSmithKline, respectively. – She currently works at Glenmark Pharmaceuticals Mexico as Senior Coordinator for Mexico as well as continuous support for LATAM and is the Head PV and TV at the National Pharmacovigilance Center. – She was recently nominated for the global award “Best New Employee” at Glenmark Pharmaceuticals. – Speaker in Pharmacovigilance and Technovigilance Course for the REGULATE Consulting Agency. – Brigade volunteer in “Brigada Amigos en el Cielo A.C.” in support of communities affected by earthquake of 19 Sep 2017 in Mexico. – She is part of the Board of Directors of the Association of Physicians and Professionals, Specialists in the Pharmaceutical Industry, A.C (AMEIFAC), actively participating in the Finance Commission since 2017.
Dr. Raghunath Dhule
Founder Member India
Experienced in using databases such as Scepter, ARGUS, Medidata Rave and have exposure to TARA system. Clinical trial involvement in cardiovascular, endocrinology, neurology and anti-inflammatory therapeutic areas. He is an effective communicator with excellent relationship management skills and analytical problem-solving abilities, willing to take up challenging initiatives. Currently working as Local Safety officer/ Pharmacovigilance Officer in-charge/QPPV with the responsibilities of responsible person for pharmacovigilance and maintaining the MAH’s PV Quality and compliance system(s). Managing the Pharmacovigilance agreement, PV Master files, preparation, maintaining of SOPs. He always Ensured quality and compliance of partner/distributors/internal stakeholders by conducting routine Safety data exchange reconciliation.
Dr. Amee Pandya
Founder Member India
Experienced research assistant with a masters (MD) in Pharmacology from Smt NHL Municipal medical college, Gujarat, India. Skilled in Clinical Research, Medicine, Clinical Pharmacology, Pharmacovigilance, GCP and clinical development. Actively involved in preparation and review of protocol, clinical trials, informed consent form, Investigator brochures, data monitoring plans, study reports, integrated summary of safety and case-based learning from actual clinical case. Been a part of many research publications and dignified awards. Always keeping up with a motto “Success is not final and failure is not fatal. It is the courage to continue that counts- Winston Churchill”