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Why take this Program CliP-PV (Proficiency in Clinical Pharmacovigilance) ?

Welcome to CliPLab, a training initiative of Cytel.
Cytel team in India is growing by leaps and bounds and today Cytel India grows to a team of 400 people spread across current locations in Pune, Hyderabad, Bangalore and Navi Mumbai. Cytel has expanded its delivery from the core SAS® Programming and statistics domain to data management, medical writing and pharmacovigilance areas. Cytel’s growth in services will be supported by CliPLab – Cytel’s unique skill development machinery by introducing various other industry focussed training and skill development programs. In a newly announced career program titled CliP-PV (Proficiency in Clinical Pharmacovigilance) spanning over 6 months, we will provide rigorous practical grooming to young graduates/professionals, hand-picked to ensure the right aptitude and potential. CliP-PV is a self-financed Job enabling initiative. The program helps you enhance your credibility as a technical professional by attaining relevant practical and theoretical knowledge.

Why Pharmacovigilance ?

The word “Pharmacovigilance” is derived from two words; Pharmaco means medicine and Vigilare means to watch. No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty called adverse effects. These adverse effects are likely to occur throughout the life cycle of a medicine starting from pre-approval stage to the post-approval. The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem is called Pharmacovigilance.

Regulatory authorities world over including India are intensifying safety regulations and thereby newer guidelines and pharmacovigilance systems are being promulgated. These regulations have compelled pharmaceutical and biotechnology companies to be alert and active in pharmacovigilance area. India has taken the lead in scaling up pharmacovigilance infrastructure and provides quality services to global pharma, biotech and medical devices companies. Multinational and national pharmaceutical companies – big and small, have started outsourcing their pharmacovigilance activities to India. This has resulted in demand for a large number of skilled and trained resources in Pharmacovigilance area offering positions such as; PV Associate, Drug Safety Associate; Drug Safety Scientist; Aggregate Report Scientist; Team Leaders, Project Managers etc.

Considering this, CliPLab launched a program CliP-PV and welcomes candidates to join this course. This course has 20 modules and at the end of the 6 months, participants should be able to understand the Pharmacovigilance Principles and Concepts, Good Pharmacovigilance practices and regulations. Practical aspects of important Pharmacovigilance activities such as adverse drug reaction, pharmacovigilance reporting – case narratives, case processing and individual case safety reports, aggregate reporting and signal detection and risk management etc.

Duration:

  • 6 months / 72 hours / Weekend Program (3 hrs daily X 24 days).

Eligibility: 

  • Pharmacy (M. Pharm., B.Pharm.,)
  • Life sciences (M.Sc. – Biotechnology, Bioinformatics, Microbiology)
  • MBBS, BDS, BHMS and BAMS

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Program Outline
The course would cover the following modules:

No. Topic
Foundation Modules
Module I Introduction: Clinical Trial Domain Overview
Module II Concepts in Clinical Pharmacology
Module III Introduction to Global Pharmacovigilance
Module IV Pharmacovigilance Methods
Core Modules
Module V Global Pharmacovigilance Regulations : USA, Europe, India, Australia, Japan, Rest of the World
Module VI Medical Coding
Module VII Literature Search
Module VIII Individual Case Safety Reports – Part I
Module IX Expectedness, Causality & Relatedness
Module X Safety Narrative Writing
Module XI Individual Case Safety Reports – Part II
Module XII Safety Writing – Aggregate Reporting (PSUR,PBRER,DSUR)
Module XIII Signal Detection – Methods & Challenges
Module XIV Risk Management
Module XV Risk Benefit Assessment
Module XVI Safety Data Exchange Agreements
Module XVII Business Models & Project Management in Pharmacovigilance
Module XVIII Special Scenarios in Pharmacovigilance
Module XIX Introduction to Pharmacoepidemiology
Module XX Safety Database

Key Benefits for recruiters-

  • Program Tailored to suit the requirements of the industry – the program is part of Cytel’s strategic initiative to build a team of talented professionals to support its business growth.
  • Possibility of quick ramp-up as the candidates are groomed on technical skills, and hands-on experience.
  • Stringent selection criteria to ensure that only serious candidates are admitted.

Key Benefits for participants-

  • A perfect blend of theoretical knowledge, practical training and coaching that helps you to become an experienced professional.
  • Mentoring by the experienced professionals from Cytel and/or industry.
  • Learn from the experts – renowned professionals who command authority in their respective fields.
  • Opportunity to build a highly coveted profile that suits the market characterized by severe shortage of experienced man-power.

Mode of Payment

  • Payment can be done by Cheque/DD/Credit Card/Debit card/Online Transfer.

Placement

  • After successful completion of six months of training, students will be provided placement assistance.