Working in drug safety is highly competitive and challenging. There is a growing need for trained professionals for the pharmaceutical industry, regulatory authorities and academia. Formal academic training in this rapidly developing subject area is lacking.

Post-authorization pharmacovigilance refers to all the activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems, from the time a product gets the authorization to be marketed in a territory. The ultimate objective of pharmacovigilance is patient safety. To ensure this, any responsible pharmaceutical company will readily vouch for the importance of all these activities, each requiring specific training for efficient and effective execution. Having a well planned job specific training curriculum can help the organization realize its goals and objectives by covering the gaps between current and desired job performance levels and existing competencies of its employees.

Apart from this, trainings can help in problem solving, increasing productivity and prepare for and respond to future changes in the organization or job duties. As the pharmaceutical business continues to grow, increasing numbers of skilled people are required to manage resultant increase in pharmacovigilance activities to remain compliant. Thus, the need for training qualified resources to develop into highly skilled pharmacovigilance professionals is the need of the hour.

Currently, the supply-demand situation for skilled manpower is highly skewed in favor of the demand, as this field is relatively new in India and elsewhere. It is interesting to note that not many resources, be it internet, literature or books, are available specifically addressing the need of the industry to guide them on training requirements to set up and maintain a competent pharmacovigilance department. This article aims to present a comprehensive perspective on the trainings required in the post authorization scenario pertaining to pharmacovigilance activities and suggest ways to manage these in an efficient way so as to be compliant with the global norms and best practices.

Key Job Functions & Profiles:

The Job profile differs from company to company but the main activities of DSM will be performing case processing, MedDRA coding, data entry, expectedness and narrative writing for ICSR. Other activities like PSUR preparation, signal detection and regulatory reporting. Medical reviewer will perform causality assessment for the ICSR and check the consistency of the data quality. QPPV will direct communication with marketing authorization holder and regulatory authorities and respond to all the queries raised by the agency and reporting of the ICSR, PSUR as guidelines. QPPV updates the SmPC / product label and CCSI accordingly.

• Junior Drug Safety Manager / Associate
• Senior Drug Safety Manager / Associate
• Team Lead
• Project Manger
• Quality Check Associate
• Quality Assurance Associate
• Medical Reviewer
• Deputy QPPV
• QPPV