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Career Aspects in Pharmacovigilance

Career Aspects in Pharmacovigilance

Pharmacovigilance or Drug Safety has a well-designed career journey with multiple career opportunities. India is widely known as one of the largest producers and exporters of pharmaceuticals in the world, with more than 8000 licensed drug manufacturers recruiting pharmacovigilance professionals. Medicines are to improve health and quality of life. 

But the same medication can sometimes damage the quality of life. Sometimes, it can even lead to severe complications and death. So, we need to be extra cautious with the risk associated with these medicines.

Increasing awareness of Pharmacovigilance globally can help avoid recurrences of serious and costly drug-related problems. Thus Pharmacovigilance is an essential tool for the progress of medicine. Patients, Doctors, Pharmacists, Nurse, and regulatory agencies have high expectations from pharmacovigilance activities, and there is always a high demand for skilled professionals in this field.
The Job in Pharmacovigilance brings tremendous responsibility as it is directly or indirectly connected to a patient’s life. It is undoubtedly one of the best career options for pharmacy and life science students curious to identify new information about the risks and dangers associated with medications. Let’s explore the career path of Pharmacovigilance.
Various Pharma Companies, CRO, BPO, KPO, and IT companies are now recruiting candidates in Pharmacovigilance.

Drug Safety Associate

Drug safety associates or DSA are mainly involved in case validation, registration, creation, data entry of all information available in the document, reconciliation, checking for minimum safety information, and follow-up process. These Individual reports are promptly prepared for submission to multiple regulatory authorities on time. The role can also involve literature surveillance, safety report identification, and review. These are generally team-based work, where each has its own set of roles and responsibilities and is still connected with others. You will find this as the entry-level job in Pharmacovigilance, and most students can resume their career after studying Pharmacovigilance. 

Drug Safety Scientist/Drug Safety Specialist

Drug safety scientist is another essential career opportunity in Pharmacovigilance. Candidate having an experience of almost 2 to 3 years as DSA can move up to become Drug Safety Scientist/Specialist. Remember, you must possess sound knowledge about medical coding, a good understanding of medical terms and a shared understanding of regulatory affairs, and narrative writing of case reports. The responsibility is to ensure that their pharmaceutical products are effective and safe. They are responsible for detecting, assessing, evaluating, and reporting on the adverse effects of drugs. Typically this will be the reviewer’s role.

Aggregate Report Scientist

Another Option in the career path of Pharmacovigilance is the Aggregate Report Scientist/Author. This involves the compilation of the safety data for a drug over a specified period, depending on country-wise regulation. One would expect good writing experience or skill in this domain.

Regulatory Associate

One can start a career in this domain, having a good interest in regulations. The job will include dossier preparation, label preparation, label update, regulatory site screening, and xEVMPD submission to the agency.

Validation

Candidates having interest and skill in the technical domain can opt for validation, testing roles in Pharmacovigilance where you will be involved in database testing, validation document preparation, testing with a regulatory agency, and being a mediator between IT & PV Operation team who understand the requirement well.

Quality Assurance in Pharmacovigilance

If one has an eye for detail and loves to be compliant, one can take up the role of quality assurance and eventually can become an auditor, which is a prestigious role.

Remuneration/Salary

Ideally, in the Pharmacovigilance Industry starting salary is from Rs. 35000/- to Rs. 50000/- per month for Medical candidates and above 20000/- for non-Medical candidates.  Freshers Package in India 

Candidates with 3-5 Years of experience and with the required skill sets (Medical coding, narrative writing, a good understanding of medical & PV terms, a basic understanding of regulatory affairs, ICH-GCP and compliance, etc.) can go on to become a DSS (Drug Safety Scientist). In this position, the monthly salary will range from Rs. 50,000 to Rs. 1 00,000 per month.

With an overall of 7 -10 Years’ experience in this position, you can quickly become a Team Lead or Team manager based on your performance, skill, quality, and the business of your company. However, the sky is the limit for experienced and skilled professionals in this domain. So, what are you waiting for? If you think you have it in you and want to see, yourself riding the ladder of Drug Safety Monitoring professionals contributing to the lives of patients, make your choice now for a bright and shining career!

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