The Pharmaceutical industry is an industry which is responsible for producing the medicines which are used to treat ailments and diseases. Creating a new drug involves a lot of research and development. The onus is on the pharmaceutical company to ensure that a newly designed drug does not have any adverse side effects and is safe to consume. In this context, the role of a drug’s safety expert becomes very important. Here are the key responsibilities of a drug’s safety expert:
Responsibility # 1 – Documenting Case Reports
A drug safety expert is involved both during the clinical trials at the start of the evolution of a medicine, and after the drug has been introduced in the market. He/She has to keep records of all the case reports, which come as feedback during the clinical trials and after the introduction of the drug in the market. Further, the drug safety expert has to process and keep track of adverse reports, following up such cases to get all the details. They also have to write reports based on independent research carried out by themselves and also share the details with stake holders.
Responsibility # 2 – Conducting Investigative Research
Usually any drug safety expert has to embark on investigative research in order to verify the claims made by the experts conducting the clinical trials. The drug safety expert additonally has to check if the adverse effect cases are indeed genuine and are not cooked up ones. To do such research, they have to read a lot of refereed journals, collect other case reports, examine lab reports and even undertake conducting of lab tests.
Responsibility # 3 – Managing Legalities
A drug safety expert also has to occasionally work with medical councils and regulatory authorities to ensure that his/her or her company is complying with all the laws, both when conducting clinical trials and when launching a drug. He/She also has the responsibility of checking if contracts and clinical trials follow the mandated safety protocols.
Responsibility # 4 – Providing Safety Information across all Departments
The drug safety expert has to provide information on the safety protocols and details about the safety of a drug across all departments of the company. In case of need, he/she has to brief the media and the general public too.
Overall, a drug’s safety expert has to be vigilant and ensure that a company never compromise on the safety component of any drug. Hence a drug’s safety expert takes care of the health of the general public indirectly by ensuring that the new medicines introduce do not pose any hazards.