Career Options in Pharmacovigilance : Gist of Pharm.D

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Today, I would like to discuss about the importance of Pharm.D in Pharmacovigilance and available career options in India.

What is Pharmacovigilance?

Pharmacovigilance is defined by the World Health Organization (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems". It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products and traditional medicines to identify new information about hazards associated with medicines preventing harm to patients. Simply it's a part of patient care and can be treated as post marketing surveillance.

An international system for monitoring adverse reactions to drugs (ADRs) was established in 1971. WHO Headquarters is responsible for policy issues while the operational responsibility for the programme rests with the WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, (UMC), in Sweden. The ADRs database in Uppsala currently contains over three million reports of suspected ADRs.

Career options:

Drug companies from many countries outsource their data to the IT companies in India due to less processing costs and availability of trained personnel. The Central Drugs Standard Control Organization (CDSCO) has made mandatory for IT companies like Accenture, Cognizant, Tata Consultancy Services, Quintiles etc to establish a pharmacovigilance centre and submit the reports on time. Outsourcing of data of major of the pharmaceutical companies will be done through IT companies, where these firms works for both clinical trials and postmarketing surveillance. - Says Akram Ahmad et al; Emerging Job Opportunities for PharmD graduates looking outside the box.

Pharm.D graduates can be hired under the PvPI programme by the Government of India, as they have relatively practical exposure to the patient centered care, Medical conditions, experience in history interview, knowledge of pharmaceutical products, as a part of their curriculum they possess expertise knowledge on pharmacovigilance and clinical research. Pharm.D graduates are practically trained to identify, assess, monitor, report and document adverse events in their clerkship and internship. The reporting is usually done after the causality assessment by Naranjo's or WHO causality assessment scale in a well designed and well structured format proposed by the PvPI under the supervision of a Registered practitioner. As PharmD graduates have expertise knowledge on patient health condition, disease state, therapeutic knowledge and evidence based practice compared to other graduates, active roles in Pharmacovigilance can be lead by PharmD graduates. By considering this the Indian Pharmacopoeia Commission (IPC) has passed a vacancy circular for 50 positions as Technical Associates as a part of PvPI programme. (For more details on Vacancy see at the bottom of the page)

Here is the schematic representation of various positions in Multinational Companies in Pharmacovigilance department: 

Drug Safety Associate manage activities relating to the collection, processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products.

1. The DSA ensures timely submission of reports regulatory agencies in accordance with applicable regulations and that all inquiries from the FDA and other drug regulatory agencies are responded to in a timely manner.
2. The DSA will respond to inquiries from healthcare professionals, consumers, and company personnel regarding safety issues with marketed products. 
3. Prepares periodic comprehensive written reviews of all assigned AEs; identify potential sources of product litigation, extract AE data from various clinical trial cases and spontaneous sources.
4. Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries
5. Ensures proper coding (MedDRA) into the global AE database.

Foot prints of Pharmacovigilance in patient safety:

Pharmacovigilance is an approach in reshaping the patient safety ensuring safety and efficacy of drugs. In 2012, over 53,000 adverse reactions to health products were reported, with almost 60% related to drugs among 79% were serious such as requiring/prolonging hospitalization or causing congenital malformation, disability or death. About one-third of reports were submitted by unspecified health care professionals and about one-quarter were submitted by physicians. Pharmacists submitted only 10% of reports, interestingly, 20% less than consumers or non–healthcare professionals. 

Source of this image: Arden R.Barry et al.; Importance of maintaining Pharmacovigilance - Canadian Pharmacists Journal 

For best details on Pharmacovigilance Visit the following websites:

1. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
2. http://who-umc.org/
3. http://www.ich.org/products/guidelines.html
4. http://www.ema.europa.eu/

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Happy Blogging...!!!

Regards,

Deepak Kumar Bandari,

Pharm.D Intern,

Vaagdevi College of Pharmacy - India

Elsevier Student Ambassador - South Asia