Key Responsibilities:
- Critically analyze large numbers of articles from biomedical published literature and internal drug safety alerts.
- Identify individual case safety reports (ICSRs) and other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products, as per applicable regulatory requirements and standard operating procedures.
- Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
- Demonstrate understanding of client’s drugs labels and use that knowledge effectively when performing the safety assessments.
- Complete drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with client’s standards of timeliness and quality.
- Use the drug safety system to track all actions and assessments in an audit-ready reference history.
- Select articles specific to client’s interest for inclusion in the client’s product literature database per guidelines.
- Write accurate, detailed, and complete abstracts of selected articles using good judgment regarding the level of detail required and excellent organization, grammar, and syntax.
- Extract key points of articles and create comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from the client’s database.
- Ensure timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
- Maintain awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
- Participate in other duties such as searches and terminology maintenance according to business needs and per the training provided.
