Clin Infotech

Teacher Name

35 Days

Build a successful career with

Pharmacovigilance Certification

Clin infotech Offer Our learners a Live Project Practical-based lab environment that enables your learners to Get Hands On Experience on the very technology to be Expert.

About Pharmacovigilance Training

Clin Infotech offers Pharmacovigilance Certification training across the India as part of Clinical Research courses. Pharmacovigilance certification training is rendered by certified, qualified, experienced Trainers in Pharmacovigilance Department and to those who are passionate about training. Our trainers are considered to be one of the best in the industry and Clin Infotech is considered to be the best Clinical Research and Pharmacovigilance training institute. Our Pharmacovigilance training endow thorough knowledge on all Pharmacovigilance Theoretical as well as Practical With Real time Scenarios. Our Pharmacovigilance course ware is meticulously designed by industry subject matter experts, which help you to get Pharmacovigilance certified. Along with the training, we offer you  e-learning access, 2 sets of   mock examinations, knowledge area wise mock tests, 35 contact hours, free online instructor.  Pharmacovigilance Project training and many more such facilities which help to up-skill your students and placement cell to get Job In more companies With Sky Rocket Increments and Salaries.

Eligibility Criteria for Pharmacovigilance Course:

Professionals who can consider Clinical Research Career as a next logical move to enhance in their careers include:

  • Pharmacy Professionals ( B.Pharamcy / M.Pharamacy / Pharm D)  from any domain who has Good analytical skills
  • Medical Professionals (MBBS / BDS/ BPT/ BHMS/BAMS/ Nursing) Freshers / Experience Professionals.
  • B.sc / M.Sc ( Biotech/ Microbiology/ Biochemisty/ Chemistry & All Life Sciences) Freshers / Expereince
  • Software programmers
  • Fresher from any Science stream with good Analytical and logical skills.

Pharmacovigilance Course Content:

  • Welcome and Introduction, History & Overview of
    Pharmacovigilance
  • Drug Development and Clinical Trial Phases
  • Pharmacovigilance Roles & Responsibilities in a CROs
    & Sponsor.
  • Pharmacovigilance Process & Life cycle
  • Introduction and responsibilities: USFDA, EMA and CDSCO
  • Pharmacovigilance in India
  • Clinical Development process
  • Different phases of clinical Trials
  • Adverse events and its types
  • Drug Safety in clinical trials and post marketed drugs
  • Different sources of Adverse events reporting
  • Different types of AE reporting Forms
  • Expedited reporting and its timelines
  • Different departments working on Pharmacovigilance
  • Roles and responsibilities of case receipt unit
  • Roles and responsibilities of Triage unit
  • Four factors for the reportable case
  • Seriousness criteria of adverse event
  • Expectedness or Listedness of adverse event
  • Causality assessment of the adverse event
  • Introduction to safety database and different types
  • Narrative writing
  • Case quality check, Medical review and its submission.
  • The Qualified Person for Pharmacovigilance (QPPV) in the
    European Economic Area
  • PSUR and its submission timelines

Why Choose Clin Infotech for Pharmacovigilance Course in Hyderabad:
Clin Infotech provides the Internship Program For Pharmacovigilance Course with Hands on Experience on Argus Safety Database.
  • CompleteCourse Material will be provided including detailed information about theentire work flow of Drug Safety Associate.
  • 2months internship available after rigorous training in Pharmacovigilance.
  • Own CRO live Projects
  • We Provide Real Time Experience on Global Drug Safety Software with PSUR
  • & DSUR Training.
  • Highest Placement record across all training institutes
  • Industrybased SOP’s training
  • Trainerswith minimum of 7+ years of experience
  • Comprehensiveteaching by Medical Doctors
  • Handson experience on Global Safety Databases used in the Industry.
  • Total150 hours of exposure to theory, case studies and practicals.
  • PracticalHands on Training will be provided on Case Processing, Narrative Writing,
  • MedDRA 16.1 & Who DRUG Coding.

Placement Support @ Clin Infotech

  Our Placement Team Will help all the trained Professionals with the Following:

  • ResumePreparation
  • InterviewPreparation with real time questions and answers
  • MockInterview Sessions
  • Mock Exams
  • CommunicationSkills and Personality development Sessions
  • PlacementAssistance
  • PlacementAssurance

 Pharmacovigilance Training Modules:

Module 1: Pharmacovigilance

  • Introduction
  • Historical Overview
  • Basic principles of Pharmacovigilance in Clinical Trials
  • Methodologies for Pharmacovigilance
  • Pharmacovigilance Regulations in Clinical Research
  • FDA and EU perspectives
  • Drug regulatory activities MedDRA
  • Regulatory aspects in Pharmacovigilance
  • EudraVigilance
Module 2 : Pharmacovigilance Regulations in Clinical Research
  • FDA and EU perspectives
  • Drug regulatory activities MedDRA
  • Regulatory aspects in Pharmacovigilance
  • EudraVigilance
  • PharmacovigilanceRegulations in clinical research
Module 3 : Adverse Drug Reactions and Safety Reporting with ORACLE ARGUS
  • ADR Reporting – an introduction
  • Causality Assessment of suspected Adverse Drug Reactions
  • PeriodicSafety Update Reports (PSUR) for Marketed Drugs (ICH E2C)
  • ExpeditedReporting Requirements
  • Individualcase safety reports
  • Electronicsafety update reports
  • WHO& safety monitoring
Module 4: Case Processing and Narrative writing
  • DataEntry
  • MedDRA/WHO-DRL/DD Coding of reported primary diagnosis & Concomitant medications
  • Case Narrative Writing
  • Query generation and forwarding of queries
  • Quality control- an overview
  • Active Case / Query follow up – an overview
Module 4 : Compliance to Clinical Safety and Pharmacovigilance Regulations
  • Review of benefits-risk assessments and management
  • Scope of Pharmacovigilance inspection and conduct of inspection
  • Internal audit of Pharmacovigilance activities of a company
  • Pharmacovigilanceinspection reports
  • Pharmacovigilancecompliance and inspection
  • QualitySystem in Pharmacovigilance: Good Practices, SOPs, Preparation for Audits& Inspections
  • Scopeof Pharmacovigilance inspection and Conduct
  • Internalaudit of Pharmacovigilance activities of a company
  • Keyfunctionalities of the Adverse Event Systems

Pharmacovigilance Certification Process:

Post completion of the training, one should take an online examination facilitated by the Clin Infotech and should attain 60% or more to complete the course and gain the Pharmacovigilance Certification.


Internship

As Part Of the Pharmacovigilance Training we Offer Internship to Get Hands on Experience on The Leading Softwares and the Complete Work Process With the Live Project Experience. This Internship aims to help students how to successfully Crack the Interview to be with stand unique in the Interview Pannel. This Pharmacovigilance Internship would be very interactive with  case studies and Project Scenarios.Mock exams will be conducted after the completion of each topic. The course material is tailored meticulously to ensure easy understanding for all the professionals or students.

To build a successful career in Pharmacovigilance Era this course is intended to give a complete understanding of Pharmacovigilance concepts. This course offers you get practical, hands-on experience to ensure hassle-free execution of real-life projects. This Pharmacovigilance course leverages world-class industry expertise in making you professional Clinical Research and Pharmacovigilance experts.

FAQs

Pharmacovigilance or PV refers to the pharmacological science that relates to the process of researching, detecting, assessing, analyzing and preventing all possible adverse impacts of medicines, both long term, and short term.

Duration Of the Pharmacovigilance Certification course is 3 Months Certification which consist of 2 Months Training Followed by One month Internship . In Pharmacovigilance Internship Period the Candidate will have total Hands on Experience and Work Process and Real Time Exposure of Complete Pharmacovigilance work on Leading clinical softwares in the Clinical Researc Industry.

Pharmacovigilance involves activities related to understanding assessment, detection and prevention of adverse effects or any other drug-related problems Pharmacovigilance is a continuous process accepted for safety evaluation accompanied by steps to improve safe usage of medicines.

Pharmacovigilance is associated with life science and pharmacy to provide unique careers to pharmacovigilance professionals that assess, monitor, detect and prevent adverse effects of drugs. This scientific discipline with role to analyse the side effects of drugs and monitor the safety of drugs available in the market touches the sectors of healthcare and pharmacy. Candidates with B.Pharmacy M.Pharmacy PharmD life sciences degree in zoology, botany, biotechnology, microbiology, biochemistry or genetics are eligible to pursue a career in pharmacovigilance. Graduated candidates are hired for different positions in pharmaceutical companies along with acquiring few job opportunities in the public sector. The responsibilities of pharmacovigilance professional include conducting the risk-benefit analysis; tracking all drug related reports; reviewing and assessing all drug related documents; entering database reports and performing label assessment.

What are The Career Opportunities After B.pharmacy M.Pharmacy and PharmD – Pharmacovigilance Drug Safety Associate?

pharmacovigilance industry always struggles for qualified medical talent which suits to the needs of the drug safety enterprise. Jobs after B.pharmacy, M.Pharmacy and PharmD could be many however the pharmacovigilance positions have the potential to take you to greater heights of the management enterprise. Albeit a lucrative career few mainstream physicians opt for a career in pharmacovigilance making ample room for the Pharmacy Grauduates.

More details are available here: Advanced PG Diploma in Clinical Research & Pharmacovigilance

As there is Huge Demand for BDS Dental Doctors For Pharmacovigilance Drug safety Associates and because of High range of Salaries and Good Promoting Options to go as medical Reviewer pharmacovigilance will be the best and best oprtion For BDS Dental Doctors.

Pharmacovigilance is considered to be one of the best career option for life science and pharmacy graduates. It mainly deals with reporting and analysing of medicine side effects and ensure drugs in the market are safe and secured.

In order to pursue a career in pharmacovigilance, the minimum eligibility criteria to apply for the course is: A postgraduate or graduate degree in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) with at least 50% marks in aggregate.

The Salary for Pharmacovigilance Drug Safety Associates are 2.4 Lakhs to 3.5 Lakhs for Pharmacovigilance Drug Safety Associates.

HYDERABAD: 19

  1. NOVARTIS
    2. PARAXEL
    3. MAKROCARE
    4. MAHINDRA SATYAMBSG
    5. DR REDDY’S
    6. AUROBINDO
    7. SRISTEK
    8. SHANTHA BIOTECHNICS
    9. NEKTAR THERAPEUTICS
    10. VIMTA LABS
    11. BIOLOGICAL E. LTD
    12. MEDHIMALAYAS
    13. SRI KRISHNA PHARMA
    14. LAURUS LABS
    15. SANTHA BIOTECH
    16. PIRAMAL
    17. GENPACT
    18. INVENTIVE
    19.GRANULES

BENGALURU: 24

  1. IQVIA
    21.Bioclinica
    22. BIOCON
    23. ACCENTURE
    24. ASTRAZENECA
    25. BLUEFISH
    26. SCIFORMIX/STRIDES ACROLABS
    27. MMS-HOLDING
    28. NORWICH CLINICAL SERVICES
    29. HCL
    30. OMNICARE CLINICAL RESEARCH
    31. MICRO LABS
    32. ECRON ACUNOVA
    33. G7 INFOTECH
    34. IMS HEALTH
    35. KINAPSE
    36. FORTIS HEALTH CARE
    37. NOVO NORDISK
    38. PHARMALEAF
    39. BIOCAD
    40. iMEDGlobal,
    41. PPDi,
    42. 4C Pharma Solutions
    43. Syngene

44.covance

MUMBAI: 15

  1. COGNIZANT
    44. TCS
    45. SIRO CLINPHARM
    46. MEDPACE
    47. SCIFORMIX
    48. PPD
    49. SYMOGEN
    50. IPCA LABORATORIES
    51. RATIOPHARM
    52. DIAGNOSEARCH
    53. UNIJULES (NAG PUR)
    54. FDC
    55. ABBOTT
    56. USV LIMITED
    57. PIRAMIL

PUNE: 7

  1. I 3 GLOBAL DRUG SAFETY
    59. SCIFORMIX.
    60. TCS
    61. EMCURE
    62. SP softtech
    63. CREST.
    64. Infocorp Software Solutions

CHENNAI: 10

  1. ICON
    66. ACCENTURE
    67. RX MD
    68. TAKE SOLUTIONS
    69. TCS
    70. COGNIZANT
    71. EMCURE
    72. INVENTIVE
    73. i3
    74. IPLEX

DELHI: 10

  1. JUBILIANT-BIOSYS
    76. APCER, DELHI
    77. WIPRO
    78. I GATE PATNI COMPUTERS
    79. APC PHARMA
    80. MANKIND
    81. IMS gurgaon
    82. SYNOGEN
    83. BESTOCHEM
    84. Symogen Limited

GURGOAN: 5

  1. KINAPSE
    86. MSD (MERCK)
    87. I 3 GLOBAL DRUG SAFETY
    88. GVK
    89. WNS

AHMEDABAD: 3

  1. LAMBDA
    91. INC RESEARCH
    92. APCER LIFE SCIENCES

CHANDIGARH: 1
93. QUANTUM SOLUTIONS

VADODARA: 2

  1. ALEMBIC
    95. SUN PHARMA(Halol)

CHENNAI: 1

96.THOMSON REUTERS

AURANGABAD 1

  1. WOCKHARDT