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Pharmacovigilance

Pharmacovigilance is a science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological, herbalism and traditional medicines with a view to:

  • Identify new information about adverse effects associated with medicines.
  • Preventing harm to the patients.

OBJECTIVES


  • Involve exhibiting the efficacy of drugs by monitoring their adverse effect profile for many years from the lab to the pharmacy.
  • Tracking any drastic effects of drugs improving public health and safety in relation to the use of medicines.
  • Encouraging the safe, rational and cost-effective use of drugs.
  • Promoting understanding, education and clinical training in pharmacovigilance.
  • Effective communication to the generic public.
  • In addition, providing information to consumers, practitioners and regulators on the effective use of drugs along with designing programs and procedures for collecting and analyzing reports from patients and clinicians conclude to the objectives of pharmacovigilance studies.

JOB PROSPECTS


  • The job for science graduate is DSA (Drug Safety Associate) this is one of the entry level jobs for pharmacovigilance professional.
  • Once an individual acquires an experience of 2-3 years in that position and builds the required skill sets (Medical coding, narrative and scientific writing, good understanding of medical terms and basic understanding of regulatory affairs, ICH-GCP and compliance etc.) he can go on to become a DSS (Drug Safety Scientist).
  • PV professional who has a good narrative writing experience can pursue it on a larger frame, moving from individual cases like writing for PSUR (Periodic Safety Update Report) and PADER (Periodic Adverse Drug Experience Reports) and as well as becoming an Aggregate Report Scientist.
  • With the experience of 7-8 years in this field PV professionals can easily become a Team Lead or Team Manager based on the company and eventually they can end up being the Director or Vice-President in the long term.

Eligibility


The minimum eligibility criteria for Advanced training courses in Pharmacovigilance and Regulatory affairs would include either of the following:

  • Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc.
  • Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc.
  • Any degree in Pharmacy / Pharmaceutical Sciences
  • Any degree in Chemistry / Biostatistics / Bioinformatics
  • Any degree in Nursing / Allied Health
  • Students pursuing graduation / post-graduation are also eligible to apply.
  • These courses can be done by the working professionals also, as they don’t have to quite their job, they can go for e-learning training program.