The PV and Drug Safety specialist is concerned with the monitoring, research and assessment of products in order to seek any new and adverse side effects that may have arisen since the clinical development stage.

Their role is focused on safety reporting for marketed products and risk management. They also make sure that all new information is made available to patients to inform them of the safe and effective use of the product.

They focus in the areas of:

• Drug Safety Risk Management
• Writing Risk Management Plan for Marketing Authorization Application Dossier
• Provision of QPPV Services
• Signal detection, analysis and evaluation
• Product Risk Management (RiskMAPs; REMS and RMPs); PIPs
• PV systems Validation
• PV Inspections / Audit (FDA, EMA, MHRA others)
• Medical review
• Serious Adverse Event (SAE) processing
• Medical management
• Good Clinical Practice
• Medical monitoring
• Aggregate reporting
• Global Safety Surveillance

The term “medical writing” encompasses different kinds of work for clients in media, government and industry. Given the volume of information that comes out of a clinical trial, there’s a lot to write about.

Pharmaceutical companies, hospitals, and other clinical trial sites, government agencies, and marketing companies (also known as medical communications companies) employ medical writers.

Pharmaceutical companies, medical-device manufacturers, and clinical-research organizations (CROs) all employ writers to prepare regulatory documents used to seek U.S. Food and Drug Administration (FDA) approval for drugs and devices.

Medical writers help doctors write research articles, monographs, and reviews on medical topics. Continuing medical education (CME) companies employ medical writers to produce educational materials and slide kits that doctors and nurses use to prepare for license renewals.

Medical writers produce sales training materials, press releases for industry, and fact sheets or Web site materials for government organizations. They also write about research discoveries for medical journals, Web sites, newsletters, magazines, newspapers, and any other medium that includes coverage of health and medical issues.

The Regional Medical Adviser (RMA) organizes unbiased interaction between the sponsoring company and the medical community. They communicate important medical information between the sponsor and the medical community. They will work with the marketing department to insure that information is accurate. The RMA fosters collaboration with Key Opinion Leaders to improve trial development, review and post-trial follow-up. The RMA is an important resource to provide answers to medical, regulatory and legal questions concerning the trial.

The roles of RMA and Medical Science Liaison (MSL) overlap significantly.

This position requires a medical degree (foreign degrees are often acceptable) and excellent leadership and organizational skills.

The Medical Science Liaison (MSL) is healthcare professional, usually with an MD or PhD, who has in-depth knowledge of the sponsor’s products, often related to one or a few therapeutic area(s) or product class(es). The MSL works as the communication interface between the pharmaceutical company and the medical community, working to help doctors and pharmacists understand their products. MSL are not involved in marketing, but are present to facilitate understanding for prescribers and users of the product. As such, the MSL is a spokesperson for the product and an educator who tries to relay information in an unbiased manner.

The MSL is involved in:

• Gathering new information about a product, including AEs and risks
• Medical training and information sessions
• Forming professional relationships with the medical community, regulatory agencies, investigators and key opinion leaders.

The roles of the MSL overlap significantly with those of the RMA.

Medical Affairs (MA) is a title with a general scope. MA involves post-marketing activities related to healthcare products. Although this department is involved with commercial products, it is intended to provide objective support for clinical and scientific activities. Like the positions of Medical Science Liaison and Medical Advisor, which can fall into the category of MA, jobs in MA involve interacting and forming relationships with stakeholders and key opinion leaders. MA professionals are those individuals who represent the medical face of the company and who should be detached from promotional and marketing activities.

The collective goal of MA is to establish scientific credibility and long-term integrity with relevant scientific, academic and regulatory groups. Communication and leadership abilities are key to advancement.

Positions under the umbrella of MA include MSL, Medical Advisor, Medical Information Officer, Medical Affairs Pharmacist, Medical Director, Medical Lead and many others.

An IRB Associate contributes to the oversight of a clinical trial by helping to review proposed protocols or with any administrative duties related to this task. To work for an IRB, the individual must have a thorough understanding of all applicable regulations, particularly with Good Clinical Practice and regional regulations (including the Code of Federal Regulations in the USA). In addition, the candidate must be an objective, highly-principled who works well in teams and exercises good professional judgement.