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PHARMACOVIGILANCE Training Course

PHARMACOVIGILANCE SCIENTIST Training Course

About Pharmacovigilance Course

Qualified Pharmacovigilance Professional training course aim to create Pharmacovigilance professionals by covering all the technical aspects of Pharmacovigilance job. The program includes 12 weeks of extensive training incorporate the unique technicalities and experience combined from our extensive team of industry professionals. The technical training on case processing with live experience on the Pharmacovigilance project gives the opportunity for candidates to excel in their Pharmacovigilance career.

Pharmacovigilance Scientist Training

Pharmacovigilance Course Learning Outcome

  • Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance
  • Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety departments, such as the QPPV (Qualified Person for Pharmacovigilance), Drug Safety Physician, Drug Safety Data Analyst, Drug Safety Associate, Drug Safety Data Entry Associate, Drug Safety Triage Officer, Drug Safety Auditor, Drug Safety Regulatory Associate, and others
  • Detailed training in MedDRA coding and medical narrative writing for SAE reports.
  • Expertise in regulatory report writing like ISS/ISE, ICSR, PSUR, PBRER, SUSAR, aggregate reports and others as required for various regulatory compliance.

Pharmacovigilance Topics Covered

  • Introduction & History of Pharmacovigilance
  • Exporting food & Ingredient and Health Supplements to USA - Europe - India
  • Pharmacovigilance complete Process
  • Pharmacovigilance Terminologies
  • Introduction & origin of Pharmacovigilance Guidelines
  • Regulatory authorities - Worldwide
  • International Conference on Harmonization (ICH)
  • Guideline on good Pharmacovigilance practices (GVP)
  • FDA 21 CFR Part 11
  • SOURCES & PROCESSING OF ICSRS
  • Rationale for Pharmacovigilance Monitoring
  • Safety in the Lifecycle of Products
  • PRE-MARKETING SAFETY ASSESSMENT
  • POST-MARKETING SURVEILLANCE
  • POST-MARKETING SURVEILLANCE METHODS
  • ICSR PROCESSING
  • ICSRs PROCESSING WITH SAFETY DATABASE & MEDDRA CODING
  • Introduction to safety databases
  • Case Processing in E2B Compliance Safety Database
  • MedDRA v20.0
  • REGULATORY REPORTING IN PHARMACOVIGILANCE
  • Expedited reporting
  • Aggregate Reporting
  • Signal Detection & Assessments

CAREER Opportunities

  • Fresher Level job in Pharmacovigilance is DSA (Drug Safety Associate). A Drug safety Associate is mainly involved in case creation, checking for MSI (Minimum safety information - a patient, a reporter, a suspect drug and a adverse event), reconciliation and follow up process, data entry of all information available in the document and medical coding
  • -3 Years of experience builds more skill sets as (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc) which can bag him a position as DSS (Drug Safety Scientist).
  • With a Certification in Pharmacovigilance and an overall of 5+ Years experience, candidates can become a Team lead or Team manager based on the company.

Eligibility

Graduates in any stream are eligible to apply for PHARMACOVIGILANCE Training Course.

Duration & Fees

  • Course Duration : 3 Months

Apply Online

Students can download the admission form by clicking here, in PDF format print and fill the same, clearly mentioning Mobile No & Course Interested.The Filled form should be courried to us along with DD at the below mentioned address.

Address:
Global Institute of Regulatory Affairs
Prestige Classic BLD,
D Wing Off G4 & 5,
Chinchwad Station,
Near Dawabazar,
Chinchwad Pune - 19
Phone – 020-46704472

Apply Online

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Testimonials

    Nakul Pathak Says

    "Regulatory Affairs program at GIRA very effectively integrates industrial experiences with academics in the pharmaceutical field. It helps you to understand the Practicalities of the rules, regulations & guidelines ."

    Nikhil Pachpute Says

    “GIRA's training institute offers high quality courses. It gave me a much needed broader perspective and a multi- faceted view of regulatory affairs. I understood the department work in depth and got a breakthrough in Regulatory Sector."

    Arun Renukuntla Says

    "Faculty at GIRA has vast industrial experience, which has been very useful for me. The teaching methodology is very innovative as well as interactive. Dedicated sessions for query solving are also there.”

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