CAREER IN PHARMACOVIGILANCE
Pharmacovigilance, which is one of the unique careers, is associated with life sciences and pharmacy and health care. This scientific discipline’s role is to analyze drug side effects.
Pharmacovigilance professionals monitor the safety of drugs that are available on the market. Whenever any effect is reported, the pharmacovigilance professionals are the ones who follow up with the case and carry out the necessary tests, etc.
Qualification: Who is qualified to do Pharmacovigilance, ideally health care students and professionals like B. Pharm/M. Pharm/Pharm. D/Ph. D/BDS/MDS/MBBS/MD/BHMS/BAMS/B. PT/M. PT and B. Sc/M. Sc (Nursing)
Introduction:
A career in Pharmacovigilance is interesting with a well-described career path. The career development is quick which gradually leads to Subject matter expert (SME), Team Leader (TL) managerial, and director positions with work-from-home options excellent pay packages. Pharmacovigilance is a good career choice for life science graduates including pharmacy, pharmacology, medicine, and alternative medicine. It is a highly advanced scientific discipline that is mainly involved with reporting and assessing drug adverse effects.
A Pharmacovigilance professional’s responsibility is to make sure that drugs available in the market are safe and those drugs which are identified as unsafe are removed from the market or appropriately labeled if the risk-benefit ratio justifies their continuous use. Once a drug adverse event is reported, the Pharmacovigilance specialists enter the event in appropriate safety databases, follow up with the case to collect more data, and forward these data to regulatory agencies and other appropriate authorities if needed, after due quality control and medical review.
Hierarchy in the Pharmacovigilance Sector :
The hierarchy of pharmacovigilance is as follows:
- Drug Safety Associate/Medical Services Associate/Trainee Junior Data Analyst
- Drug Safety Scientist
- Aggregate Report Scientist
Drug Safety Associate/Medical Safety Associate/Trainee Junior Data Analyst :
The Entry level job in Pharmacovigilance is Drug Safety Associate (DSA). Drug Safety Associates are mainly engaged in case of development, examining for Minimum safety information (MSI), reconciliation and follow-up procedure, data entry of all details available in the document, and medical coding.
ROLES AND RESPONSIBILITIES :
A Drug Safety Associate is responsible for assessing the safety of pharmaceutical drugs once they’re on the market.
Using standardized guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to the pharmacovigilance department.
Every drug safety associate is an asset to the pharmacovigilance department in operating its day-to-day activities.
The basic authority given to a drug safety associate is to overview the adverse events that occurred to be identified and reported.
Drug safety associates liaise with most healthcare service providers for safety and efficacy aspects.
Drug Safety Scientist/SME :
Once a professional attain an experience of 2-3 years in a DSA position and builds the necessary skill such as Medical coding, scientific writing and narrative writing, a great understanding of medical terms and a primary understanding of regulatory affairs, ICH-GCP and compliance, etc, he/she can go on to become a Drug Safety Scientist (DSS).
ROLES AND RESPONSIBILITIES :
- To ensure that most of the safety reports that are received from the investigational sites or from the post-marketing sector must be identified & reported.
- Reports that are collected must be organized based on the seriousness or effectiveness of the drug initially.
- An overall consistency in assessing the adverse reaction reports must be accurate & legible.
- Must be judgmental in taking appropriate decisions by applying their knowledge of FDA & ICH-GCP standard regulations.
- Must be able to communicate with clinical physicians in drug safety and assess case report forms.
Aggregate Report Scientist:
Professionals who have obtained excellent narrative writing skills can work on many critical tasks like individual case narratives, PSUR (Periodic Safety Update Report), and PADER (Periodic Adverse Drug Experience Reports) development and are referred to as Aggregate report scientists.
ROLES AND RESPONSIBILITIES :
- Monitor and manage the quality of documents to meet both internal SOP standards and external regulatory standards.
- Provide inputs and value add from medical perspective at all stages of safety deliverables
- Be completely accountable and responsible for assigned activities like writing, review, coordination, project management and leading the projects.
Team lead :
With an overall of 5-6 years of experience in Pharmacovigilance, an individual can become a Team lead or Team manager.
ROLES AND RESPONSIBILITIES :
A team leader’s main responsibilities include:
- Organizing work
- Communicating goals
- Connecting work to context
- Delegating tasks
- Leading by example
- Allocating and managing resources
- Problem solving
- Managing project progress
- Reporting progress to stakeholders
- Coaching to improve team member skill sets
- Motivating team members to accomplish their goals
- Nurturing team member strengths and identifying areas for improvement
- Representing and advocating for team needs
Director :
Finally, professionals move on the management hierarchy and with further experience and business skills move to directorial roles within 10-15 years.
A career in pharmacovigilance is a great option for life science and pharmacy graduates. Be part of a company that is experiencing steady growth, and committed to rewarding talent, and continuing professional development programs that attract and retain the very best in our industry.
At a fresher level, you will be hired as a Drug Safety Associate who primarily engages in case triage, creation, narrative and scientific writing, and medical coding. As you develop an understanding of ICH/GCP guidelines and regulatory practices, you will develop your scientific review of adverse events to become a Safety Scientist.
Based on your experience in a particular set of activities, you can become an aggregate report scientist, risk management specialist, signal detection scientist, or medical reviewer if you are a medical graduate.
In 6-8 years, individuals attain the position of Associate Director, Director, or Vice-president, based on their organizational needs and contribution.
How To Pursue :
A Career in Pharmacovigilance Candidates who have graduated or post-graduated with Pharmacy/Dental/Nursing/Medical and Physiotherapy background are eligible to pursue this field.
Conclusion:
Current progress in pharmacovigilance is marked by the increasing use of databases and by attempts to make the process more proactive and organized. Attempts are being made to augment the spontaneous, random nature of the generation of pharmacovigilance data and to make the process more systematic and structured. These changes are emphasized by the recent guidance documents for the industry by both EMEA and FDA on pharmacovigilance planning and risk management. This emphasis on planning a pharmacovigilance program for a drug and trying thoughtfully to minimize risk appears constructive and, to some of us, long overdue. Notably, the emphasis on proactive safety planning is linked with an expectation that the suspicions arising from spontaneous reporting will rapidly be tested by formal pharmacoepidemiologic studies conducted in organized and validated databases or prospective studies.
Article Written By : Kumar, B. Pharm, Supriya. N, B. Pharm, Saastra College of Pharmaceutical Education and Research, Kakupalli Nellore and Sattar Shaik, Priyadarshni Institute of Pharmaceutical Education and Research, Guntur.
Reviewed and Finalized by Kiran Kumar. CH, Career Growth Coach, Rise Trainings.
