Free Counselling
Call Us
PG Diploma Advanced Clinical Research & Pharmacovigilance in Dehradun
Dehradun Campus
PG Diploma in Advance Clinical Research & Pharmacovigilance
Duration -10 Months
Enquiry Form
I agree to receive information regarding my submitted applicaton by signing up.
Scope of The Course
  • Vacancies
    INR 3.5 Lacs to INR 5.5 Lacs PA

    Starting Salary Package

  • INR 3.5 Lacs to 6.0 Lacs
    INR Over USD 261 billion

    Industry Size

  • U$D 16
    25 lac positions globally

    Positions vacant

PG Diploma in Advance Clinical Research & Pharmacovigilance
 
What Will You Read?

Delivered through fourteen focused modules spanning over ten months.

Module I – Introduction to Clinical Research

Module II – Basic Pharmacology and Pharmacy in Clinical Research

Module III – New Drug Development

Module IV – Ethical Guidelines in Clinical Research

Module V – Ethics in Clinical Research

Module VI – Regulations in Clinical Research

Module VII – Biostatistics in Clinical Research

Module VIII – Specialist Clinical Trials and Clinical Trial Designs

Module IX – Clinical Trial Documentation

Module X – Quality in Clinical Trials

Module XI – Clinical Data Management

Module XII – Clinical Trial Management

Module XII – Drug Safety and Pharmacovigilance

Module XIV – Soft Skills for a Clinical Research Profess

Eligibility

Minimum eligibility criteria for application to the course would be either of the following:

MBBS/BAMS/BDS/BHMS/Physiotherapy and Occupational Therapy Graduates/B.Pharm/M.Pharm.

Graduates/ Post-Graduate Diploma In Clinical Research/Life sciences/ BioSciences with any of the following subjects-Chemistry, Botany, Zoology, Biochemistry, Microbiology, Genetics and Biotech with min 50%.

What Will You Become
    • For Doctors: Principal Investigators / Co-investigator / Medical Advisor / Drug Developers / Regulatory Affairs Manager / Clinical Research Physician.
    • For Paramedics, Pharmacists & Life Science Graduates: Medical Writers / Clinical Research Associates / Site coordinators / Clinical Research Manager / Drug Development Associates / Clinical Data Management / Pharmacovigilance Executive / Clinical Trial analyst / Drug Reviewer / Drug Safety Physician & many more
    • For Management Professionals: (with Life Science/Health Science background) Business Development / Clinical Project Management / Clinical Research Management / Regulatory Affairs.
    • Clinical Research Associates: To monitor clinical trials, ensure compliance with the clinical trial protocol, checks clinical sites activities, make on-site visits, CRFs.
    • Clinical Research Investigators: Conduct BA/BE studies, writing / revising SOP, review of protocols, investigators brochures, ICF & CRFs Protocol, CRF & ICF preparations plans and conduct of BA/BEIEC/IRB affairs-GC.
    • Study Coordinators: Provides safety & protection while collecting & managing the study data.
    • Data Manager / Biostatistician: Design, study & predict the seriousness of the disease, seriousness of the disease, evaluate new treatment and effectiveness of medication, participate in research design, data collection, choosing & implementing appropriate methodologies, interpreting the results.
    • Regulatory Affairs Managers: Review & registration of documents, evaluation of technical data, liaison with regulatory authorities.
    • Clinical Trials Auditors: Conduct audits for regulatory function within the trial department to assure compliance with GLP/GCP in accordance with established FDA regulations and company policies & standard operating procedure.
    • Clinical Research Managers: Manage, supervise, train, mentor clinical research staff, approve investigator’s study, budget & contract, review & approve regulatory documents, develop a protocol, approve CRFs, review study data.
    • Business Development Manager: Identify potential clients, establish business relations, responsible for meeting new clients, following up on leads, market research.
    • Drug Safety Associate: Manage & relay drug safety information, maintain current knowledge of global drug safety regulations, summarize clinical safety data, write narratives with medical input, report SADRs to Regulatory Authorities, participate in training on drug safety issues & another task under drug safety.
    • Medical Writer: Documentation, manuscripts, abstracts, external communication tools Clinical Data Manager: Ensures the accuracy & consistency of data prepared for regulatory bodies for reporting purpose.
    • Others: Auditors, Quality Assurance, Patents & IP Related position

     

    Where will you work:

     

    • Bioengineering companies- Serum Institute Of India, Panacea Biotech Ltd, GlaxoSmithKline, Bharat Serums
    • CROs - Excel Lifesciences, Clinigene, IQVIA, PARAXEL, Panacea
    • Hospitals – Apollo, Max, Fortis etc
    • Life-Division of IT Companies – Accenture, TCS, Cognizant etc
    • Pharma Company – Cipla, Novartis, Ranbaxy
    • Medical device companies- Abbott Laboratories, Johnson & Johnson, Novartis AG, Siemens Healthineers, General Electric
    • Medical Colleges-  AIMS, BAMC, Maula AZAD, Mahavir Medical College,
    • Cosmetic Companies- Biotique, Lakme, Sugar Cosmetics, Mamaearth
Industry Exposure
  • India’s 1st Institute
  • India’s 1st Institute
  • India’s 1st Institute
Industry

    Clinical research Industry: Global & Indian perspective

    • The global clinical trials market size was estimated over 50.0 billion in 2022 and is expected to reach to USD 84.43 Bn by 2030 with a registered CAGR of 5.7% during the forecast period 2022 to 2030.
    • The market was further driven by  COVID-19 pandemic and the importance of making India as a hub for conducting clinical trials. The large number of patients also highlights the growing demand for treatments and immunizations. Currently, 288 medicines and 106 vaccines are in various stages of development, with almost 7.0% of therapeutics in Phase IV, 21.0% in Phase III, and 43.0%, 13.0%, and respectively, Phase II and Phase I.
    • These rules have brought India's regulatory framework on par with U.S. Food and Drug Administration (FDA) norms and now India is among the top choices for global clinical trials. India's clinical trials market is expected to reach $3.15 billion by 2025 with a compounded annual growth rate of 8.7%.
    • A new set of rules in place since 2019 is beginning to make India an attractive destination for big pharma to conduct clinical trials in India.
    • Today, around 50,000 clinical research professionals are required in the clinical research industry.
Call Now
Apply Now