Amit Gupta
Principal Medical Writer, SME (Aggregate Reports), Molecule Lead
Panchkula
Summary
- More than 11 years of experience in Pharmacovigilance activities including expertise in coordinating the preparation of several documents, including Periodic Benefit Risk Evaluation Reports (PBRERs), aCO, RMP (including RMP IPs), IB, PADERs, SSR report, Drug Safety Reports (DSRs), Development safety update reports (DSUR) and ad-hoc reports (including Health Authority Request).
- Expertise in reviewing and coordination of regular signal detection activities. Trained and mentored medical writer in various activities of
aggregate reports.
Expert in case processing of Individual Case Safety Reports which includes triage, coding, validation and quality review. - Performing medical review of ICSRs to ensure high quality of the safety reports in accordance with client SOPs and regulatory requirements. Trained and mentored PV scientists in various activities of case processing.
- Trainer in Learning and Development programme for Parexel.
Overview
11
11
years of professional experience
5
5
Certifications
Work History
Principal Medical Writer
Parexel International
Chandigarh
01.2003 - Current
- Molecule lead and managing Team of 15+ colleagues
- Handling all aggregate reports of Neuroscience therapeutic area
- Expert in coordinating and preparation of PBRERs, aCO, DSURs, RMP IPs, Drug Safety Reports (DSRs), and ad-hoc reports (including Health Authority Request
- Expertise in performing signal detection activities involving case analysis
- Literature review for detection of potential Safety Signals.
- Expert in Medical review of individual cases, tracking of important targeted medical events.
- Assessment and preparation of Signal assessment reports including case assessment, literature and epidemiology.
- Skilled in performing safety review of class label drugs.
- Identified and leveraged resources to understand underlying science and product strategy
- Successfully managed multiple projects simultaneously while maintaining strict deadlines and high-quality output
Education
Ph.D. - Pharmacology
Chitkara University
Rajpura, IndiaMaster of Pharmacy - Pharmacology
ISF College of Pharmacy
Moga, India 04.2001 -
B.Pharmacy - Pharmacy
Kurukshetra University
Kurukshetra, India 04.2001 -
Skills
Health authority commitments
undefinedSenior Senior Drug Safety Specialist
- Expertise in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs), which includes triage, initiation/registration, duplicate searches, coding, case summaries, causalities assessment, CIOMS comments, and data validation.
- Expertise in MedDRA coding and MedDRA updating as per latest version applicable.
- Maintaining good working knowledge of Reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations.
- Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Certification
Design and Interpretation of Clinical trials, Johns Hopkins University, U.S.A
Accomplishments
- Best paper presentation award at Doctoral Consortium at Chitkara University, Nov 2021
- Emerging Scientist Award by Loqman, National and International awards, Supported by Institute of Entrepreneurship Development, Govt. of U.P, 2019
- Young Scientist in BIOMEDCON-2018; National conference on Recent Advances in Biomedical Science: Diagnosis and Research, University of Delhi, 2018
- Qualified and awarded scholarship in GPAT 2010 with 92.36 percentile (National level scholarship Exam)
- Winner in Rostrum (2006, 2008, 2009) an annual public speaking competition at intra department level of Kurukshetra University, Haryana (2009)
- Won 3rd prize in poster making competition during pharmacy week in Institute of Pharmacy, Kurukshetra University, Haryana (2009)
- Won 3rd prize in seminar presentation during pharmacy week in Institute of Pharmacy, Kurukshetra University, Haryana (2009)
Professional Internship Training
- Serum electrophoresis, Tumor xenograft / Orthotopic transplantation and in-vitro cell culture, Jawaharlal Nehru Cancer Hospital and research centre, Bhopal, M.P, 2011
- Quality and product development, Chemical Resources, Panchkula, Haryana, 2009
- Quality assurance and quality control, Alkem Laboratories, Baddi, Himachal Pradesh, 2009
Seminars Conferences Attended
- Pharmaceuticals: Bench to Bedside- Challenges, Recent Initiatives and Future Perspective in National Pharma Conference-2k19 organized by Pharmaceutical Royal International Society and Bhabha University, Bhopal (M.P.)
- Recent trends in research for the treatment of diabetes associated complications in National Conference on Recent Advances in Biomedical Science: Diagnosis & research in University of Delhi, India (2018)
- Advancement in Bioanalytical Technique in diagnosis of cancer in National conference on Advanced Bioanalytical Techniques, Artificial Intelligence and Health Sciences, ISF college of Pharmacy, Moga, India (2018)
- Herbals in Diabetes associated Complications in 2nd National conference on recent advances and challenges in healthcare in GD Goenka University, Gurugram, India
- To evaluate anti-tumor activity of hydroalcoholic extracts of melia azadarach and melia dubia in Indo - Taiwan International Workshop at ISF College of Pharmacy, Moga, Punjab (2011)
- Reactivation of p53 gene a novel strategy to combat cancer in APTI-Con held at ISF College of Pharmacy, Moga, Punjab (2011)
- The futuristic approach inhaled insulin in the management of diabetes mellitus in international conference on recent advances in cardiovascular approach (RACS-4) at DIPSAR, Delhi (2010)
- Phytochemical and pharmacological profile of feronia elaphantum in National conference on innovations in drug discovery and research Punjabi University, Patiala, Punjab (2009)
- Review paper topic in silver jubilee conference of IPGA held in I.S.F College of Pharmacy, Moga, Punjab (2009)
- Nanobiotechnology and its Applications in Drug Delivery System in Yuva Vaigyanik Sammelan at NIT Kurukshetra (2008)
Publications
- Exploring protein tyrosine phosphatases (PTP) and PTP-1B inhibitors in management of diabetes mellitus
- Neuro-protective effect of Tecoma stans leaves extract against STZ induced Diabetic Neuropathy
- Exploring the multifaceted role of TGF-β signaling in diabetic complications
- Natural and Synthetic Agents Targeting Reactive Carbonyl Species for combatting Metabolic Syndrome
- A Spotlight on Underlying the Mechanism of AMPK in Diabetes Complications
- Therapeutic potential of Nrf-2 pathway in the treatment of diabetic neuropathy and nephropathy
- Exploring the recent molecular targets for diabetes and associated complications
- Mechanistic insights into the role of pyroptosis in rheumatoid arthritis
- Mdm2-P53 Interaction Inhibitor with Cisplatin Enhances Apoptosis in Colon and Prostate Cancer Cells In-Vitro
- Proposed mechanism of Tecoma stans in diabetes associated complications
- Recent Milestones in the Diabetes Research: A comprehensive Update
- A review of phytochemistry and pharmacology profile of Juglans regia
- Insights into the role of Endostatin in Obesity
- Reactivation of p53 gene by MDM2 inhibitors: A novel therapy for cancer treatment
- Unexplored Potential of Traditional Chinese medicine in Diabetes Associated Complications
- Intercalating the role of microRNAs in cancer: As enemy or protector
Timeline
Principal Medical Writer
Parexel International
01.2003 - Current
Master of Pharmacy - Pharmacology
ISF College of Pharmacy
04.2001 -
B.Pharmacy - Pharmacy
Kurukshetra University
04.2001 -
Ph.D. - Pharmacology
Chitkara University
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