Medical writer

Pharmacovigilance Medical Writer – A promising career for healthcare professionals.

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Pharmacovigilance is a great career option for life science and pharmacy graduates.

On securing a pharmacovigilance job, you will be dealing with reporting and analysis of side-effects of drugs to ensure the safety of drugs being launched in the market.

About Pharmacovigilance

Pharmacovigilance/Drug safety, is the developmental phase of a drug which involves collection, detection, assessment, monitoring, and prevention of adverse effects of a drug.

Pharmacovigilance determines the adverse events crossing the line of a drug’s efficacy. In simple words, it decides which side-effects of the drugs are worth the risk for patients while treating diseases.
Pharmacovigilance Medical Writer

You as a medical writer, could play significant role in the space of pharmacovigilance. Honing good medical writing skills not only helps in writing pharmacovigilance documents but also plays an important role in the project management of drug safety studies.

Medical writers who are familiar with Pharmacovigilance (PV) documents along with multi-disciplinary team management skills, data analysis and ability to meet challenging deadlines have a great career path in the drug safety domain. You will be involved in the development of patient safety presentations, profiling of the drug’s benefits/risks and documentation of the specific company’s risk management assessments in a timely and efficient manner, which will then be submitted to regulatory bodies.

The ‘Scientific Writing’ module in ICME’s online medical writing training program helps you in drafting scientific documents. The ‘Clinical Research and Regularly’ module makes you familiar with clinical development and pharmacovigilance. The ‘Medico-Marketing’ module helps in crafting persuasive content for the post-marketing phase of drug development.

Previous Article – Publication Management Tools That A Medical Writer Must Know

Medical writer

Publication Management Tools That A Medical Writer Must Know

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A medical writer is responsible for developing medically accurate documents for different stakeholders in the healthcare industry. Biomedical industries, hospitals, CROs, publication houses and MedComm agencies usually have an inhouse team of medical writers to develop high-quality medical documents. The responsibilities of a medical writer involve drafting, reviewing, editing, inter-team communications, being compliant to the guidelines and perform various other project management tasks. To establish a seamless workflow, the companies provide their medical writing teams with publication management tools or content management software. It is essential for a medical writer to have knowledge about these tools to perform their tasks comfortably. Here are the two tools that are widely used:

Datavision: It is a well-established publication planning software tool that is widely used in healthcare industries. This planning software helps a medical writer in project management and ensures the timely delivery of the project without compromising the expectations of the authors and the stakeholders.

Datavision is a user-friendly and intuitive tool that understands the importance and process of publication procedure. It is built around three workflows that encompass the overall publication procedure such as planning, project execution, tracking and reporting.

Some unique features of Datavision software include:

  • Writers Workbench: Medical writers can access Datavision through their desktop application or through a specialised web-based portal known as Writers Workbench. This feature allows the writer to plan their works or overdue tasks, thus, enabling the writers to manage their time and tasks effectively and efficiently.
  • Built-in Journals and Congress database: Datavision has the largest abstract and citation database with peer-reviewed literature from more than 5,000 publishers. It serves as an invaluable resource to writers.
  • Document tab for reviews and approvals: One of the core features of Datavision is the Documents tab. This tab facilitates direct management of all the elements related to a specific project. It helps manage the time plan for the project, drafts, reviews, and approvals together with feedback as the project enters its final stages.

Veeva Vault: It is a proven cloud enterprise content management platform which is specifically built for life sciences. This content management platform has a unique ability to manage both content and data on a single platform. It is designed with perfection to meet the most rigorous commercial, clinical, regulatory, quality and safety requirements. It enables the organizations and/or biomedical engineers to quickly manage end-to-end processes related to the content, data, and workflows.

Unique features of Veeva vault include:

  • Content Capabilities: Veeva Vault platform is a highly versatile tool that helps manage documents, videos, and images with high capability including electronic signatures, watermarks, templates, versioning, annotations, lifecycles, sharing and document generation. It also supports the complex business requirements needed for compliance, collaboration, and records management.
  • Easy access to Microsoft office and high optical character recognition (OCR): Veeva Vault users can check out their Microsoft office documents and can utilize the full co-authoring capabilities with a single click. The platform automatically scans, extracts, and indexes text within documents and also find images and PDF files that are uploaded directly or through Veeva Snap.
  • Dynamic Security:  The Veeva Vault platform addresses all the security challenges of global enterprises. It provides flexible authentication and authorization for the organization and the external partners. It has a dynamic security model that supports multiple domains, and fine-grain access control to functions, objects, and data.

A clear understanding about these tools will help the writers to track and manage the entire publication development process without any assistance. These tools will ensure that publications are delivered according to best practices and with highest standards.