Drug safety is also known as pharmacovigilance is an integral part of the health industry. The career as a Drug Safety Specialist or Pharmacovigilance is interesting with a well laid-out career graph starting from drug safety associate or pharmacovigilance officer going up to Vice President or Director level role. It is necessary to understand the role of the Drug Safety Specialist before deciding on pursuing a career in this field. A lot of information about drug safety as a career option is available on the Internet.
Pharmacovigilance is a science of detection, evaluation, prevention and reporting of side or adverse effects of drugs both long-term and short-term. Pharmacovigilance Officer constantly monitors the safety of drugs included in clinical trials and drugs already released in the market. In case any adverse effect is detected, they follow up, collect more information and report the matter to appropriate regulatory authorities.
The Drug Safety Specialist is involved in following activities.
- Case creation which involves the recording of minimum safety information, such as patient details, reporter details, suspect drug and adverse outcome.
- Follow-up on the case
- Entering relevant details in safety database to be evaluated by risk management teams
- Review & access all source documents
- Execute labelling evaluation of adverse effects
- Accessing adverse event vis-à-vis adverse events formerly reported
The technical role has two options, signal detection or risk management role. These roles require much higher degree of scientific knowledge. In signal detection, a person is supposed to uncover underlying reasons for patient side effects based on data trends. In the case of risk management, they a risk /benefit analysis based on data provided by signal detection team. They also make recommendations on actions that need to be taken to augment the risk.
The associates earn an entry level salary of US$ 60 -65000 going up to US$ 135000 p.a. as they gain 10+ years of experience. Drug Safety specialists find job opportunities in diverse organizations such as -
- Pharmaceutical companies
- Contract Research Organizations (CROs)
- Bio-Tech companies
- Knowledge Processing Outsourcing (KPOs) companies such as Accenture, Cognizant, iGate, etc.
- Regulatory Authorities
- Health Authorities
- Drug Safety Consultants
It is challenging for a person to transition from a line management role to a senior technical role in later part of his or her career because it is difficult for a pharmaceutical company to depend on someone without a proven experience in a similar role.
Though large pharmaceutical companies are considered good for most jobs, these are not good for gaining all round experience. In these companies, the case writing teams and technical teams have very limited interaction as they are mostly located on different sites, mostly in different countries.
To get all round exposure, a Drug Safety Specialist or PV Officer should choose to work in the following locations
- In small pharma companies as they provide a wider scope of work to individuals due to limited resources.
- On Global sites rather than affiliate sites which allow them greater interaction and opportunity to work alongside technical teams.
- For Drug safety consultants as they provide outsourcing services to many companies, which allow them exposure to high volume of work with the large number of products and customers.
The job market for Drug Safety Specialist is attractive with good compensation package and varied opportunities for work. Long-term career objectives should be kept in mind while starting your career. Some research can help in deciding the right company to join.