As a member of our team, you will play a key role in analyzing literature citations for individual case safety reports (ICSRs) and identifying other potential safety-relevant information impacting the risk-benefit and/or safety profile of our clients’ products.
Qualifications and Experience:
- Master’s Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- 1 to 5 years of experience reviewing biomedical literature for adverse event reporting OR equivalent combination of education and experience
- Writing skills to support the creation of succinct, accurate, and precise summaries and working knowledge of biomedical terminology, drugs, and therapeutic areas.
Preferred Qualifications:
- Certification from a professional medical writer’s association.
- Experience with commercial and client-specific biomedical literature databases.
- Scientific/medical writing background.
Key Responsibilities:
- Critically analyze large numbers of articles from biomedical literature and internal drug safety alerts to identify ICSR criteria and other potential safety-relevant information.
- Write brief narratives summarizing ICSR criteria and other safety-relevant information in each article.
- Utilize knowledge of client’s drug labels during safety assessments.
- Complete drug safety review of biomedical literature batches in a timely and accurate manner.
- Track all actions and assessments in a drug safety system for audit-ready reference.
- Select and summarize articles for inclusion in the client’s product literature database.
- Write detailed abstracts and create comprehensive indexes of abstract contents for literature retrieval.
- Ensure timely completion of indexing and abstracting of articles for assigned drugs in line with regulatory deadlines.
- Stay updated on new drugs, therapeutic categories, disease entities, and changes in biomedical terminology.
