The Medical Science Liaison is similar to the Medical Advisor, except their focus is more on the development of relationships with Key Opinion Leaders (KOL's) in the field. Their role is primarily to educate medical leaders with regard to company products, ongoing clinical trials and to present findings and expert opinion at advisory boards meetings and symposia in their therapeutic area. They act as a liaison between the company and the healthcare community on all matters pertaining to Medical Affairs.
The Medical Advisor offers expert clinical advice and guidance to key customers (both internal and external) and builds continuing professional relationships with key opinion leaders in the industry and healthcare system. The Medical Advisor is responsible for medical education programs, implementation and design of local clinical
trials and medical management of company products.
The Pharmacovigilance Officer (PVO) is responsible for the monitoring and reporting of adverse effects from company pharmaceutical products on the market. This information is supplied to the PVO by medical representatives, patients, doctors and other healthcare professionals in the field. It is the responsibility of the PVO to
ensure that this data is suitably recorded, analyzed and accurately processed while building strong collaborative relationships with medical affairs, commercial affairs
and corporate (Global) pharmacovigilance (PV) functions. The PVO informed opinions will help the company maximize product safety and performance.
Medical Informations Officer (MIO)
The Medical Information Officer (MIO) provides up-to-date and relevant medical, technical and pharmaceutical information on the company's marketed, discontinued or pipeline products to internal and external customers. Communication skills, both written and verbal are highly sought after with important relationships being built with external customers and internally with other colleagues in Medical Affairs, including medical advisors, medical and scientific liaisons, pharmacovigilance and outside the department in sales and marketing.
The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.
The Medical Director within a pharmaceutical company is responsible for the management of the Medical Affairs Department (Medical Information, Pharmacovigilance, Regulatory Affairs, Quality Management and Clinical Research), the design of clinical trials and the provision and coordination of therapeutic area training to commercial affairs and marketing. The Medical Director is a strategic Senior Management position with the company.
Quality Assurance Officer
The role of the Quality Assurance (QA) Officer within the Medical Affairs department differs from that of a QA Officer within a manufacturing environment. They are tasked with Quality Assurance at a corporate level and must develop and maintain quality systems for both Medical Affairs and the Sales and Marketing departments. They follow quality guidelines from Pharmaceutical and Healthcare Association, Medicines Board and from Global HQ.