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Career in Pharmacovigilance and Medical Writing

Medical WritingPharmacovigilance

Career in Pharmacovigilance and Medical Writing

Pharmacovigilance medical writing is providing new job opportunities to personnel with skills in pharmacovigilance, data presentation and medical/scientific writing. The scientific or medical information delivered in this field embraces several disciplines that are service oriented for clinical research and market authorisation.

Pharmacovigilance Medical writing

Pharmacovigilance is a discipline concerned with increasing safe usage of therapeutic drugs, biologicals and medical devices by identifying, validating, evaluating, quantifying and minimizing the adverse effects. Pharmacovigilance is a scientific process of monitoring medical practice to identify patterns of adverse effects; assessing the benefits and risk associated with medicines to improve their safe usage; providing information to optimise safe and effective use of medicines along with evaluating the impact of any action taken. Medical writers usually work with experts of pharmacovigilance, biostatistics, project and clinical data management to deliver accurate, cost effective, ethical and scientific standard documents. This involves working closely with scientists, managers, pharmacologists, pharmacists, biochemists, chemists, microbiologists, toxicologists, regulatory or marketing staff of research and development in the healthcare environment.
Pharmacovigilance medical writersprepare relevant documents at various stages of clinical development, marketing authorisation and post marketing stage of drug development process. Each document follows regulatory framework and guidelines that governs the content of documents, source data, departments and functions involved in document preparation, review and planning activities to meet appropriate timelines and product requirements. Pharmacovigilance writers analyse drug efficacy and safety to bridge information between public and medical health professionals to foster a sense of trust on use of medicines.These writers offer medical writing function of educational material, manuscripts, journal or conference submission, medical marketing reviews and reports to professionals or patients of healthcare and pharmaceutical industry. The expert writers ensure full compliance and clarity of scientific data in accordance with customer requirement.This includes regulatory writing; protocol and amendment writing; brochures development; safety writing; narrative writing; article and review paper writing; poster, abstract and publication writing; providing promotional and educational material.

Courses and Job opportunities in Pharmacovigilance and Medical Writing

Keeping customers updated with medical, scientific and commercial views or information by providing researched information on the topics is important responsibility of the writers that requires specialist and generalist skills. Skilled and trained medical writers use publication strategy to support scientific knowledge in manuscripts and other documents. Online courses and training in pharmacovigilance and medical writing solidifies basic foundation in operations related to medical writing in pharmacovigilance. The curriculum is fully supported by professionals and relevant to aspirants interested in pharmacovigilance or medical writing sector of pharmaceutical industry. Pharmacovigilance positions with extensive scope of knowledge are found in clinical research organizations, biotechnology firms and pharmaceuticals companies in medical, academic and life science industry.
Aspirants with science degree or postgraduate qualification or a scientific PhD degree need information management training, development training and attend annual conferences for continuing and updated education. Strong organisational, interpersonal, communication and presentation skills are essential to convey and communicate information to the target audience in an appropriate manner.Technical skills with new technological developments are required since company data, published literature and other information are routinely stored, retrieved, manipulated, distributed and transmitted electronically through computers, commercial systems, databases and internet to customer using traditional methods or interpersonal contact.

Online Courses in Pharmacovigilance and Medical Writing

James Lind Institute (JLI) provides an online program – Advance PG Diploma in Pharmacovigilance & Medical Writing for better job opportunities in this growing field. JLI also provides online courses in Clinical Trial Management, Regulatory Affairs, Quality Assurance, Medico-marketing and Medical/Healthcare Journalism.
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