Job Description

Job Duties and ResponsibilitiesExperienced in Conducting structured searches of scientific literature databases, including PubMed, Embase, and others, using predefined search strategies and keywords. Screen search results to identify relevant safety information, including adverse events, safety signals, and emerging risks associated with assigned products. Experienced in Conducting a secondary evaluation of references that have been screened and submitted by primary screeners to the customers database. Possesses experience in the Indexing of abstracts from literature. Works closely with the manager to provide constructive feedback to primary screeners who fail to report AEs. This collaboration aims to enhance the quality of AE reporting. Stays updated on new pharmaceutical developments and therapeutic categories, emerging diseases, and modifications in biomedical terminology in the published literature. This awareness helps in maintaining the accuracy and relevance of the work. Extract pertinent safety data from selected literature sources, ensuring accuracy, completeness and adherence to established protocols. Compile and organize extracted data in a clear and structured format for further analysis and review. Collaborate with the Pharmacovigilance team to escalate potential safety signals and Valid ICSRs for further evaluation and risk assessment. Evaluate literature reports for potential cases of adverse events or safety concerns requiring further investigation. Maintain clear and detailed documentation of literature screening activities, including search strategies, screening criteria, and data extraction methods. Prepare concise summaries of literature findings and safety assessments for internal reporting purposes. Ensure the accuracy and reliability of literature screening activities by adhering to standard operating procedures (SOPs) and quality control measures. Effectively communicate literature screening findings and safety assessments to internal stakeholders. Collaborate with cross-functional teams to provide timely updates on relevant safety information and contribute to risk management decisions.Minimum Qualifications

• Bachelors/Masters degree in Pharmacy, Life Sciences, Nursing, or related field. Advanced degree (e.g., PharmD, MD, PhD) preferred.
• Previous 2-3 years of experience in pharmacovigilance, medical literature analysis, or related field within the pharmaceutical industry, preferably with experience in literature screening.
• Strong understanding of pharmacovigilance principles, adverse event reporting requirements, and regulatory guidelines.
• Familiarity with scientific literature databases and search techniques (e.g., PubMed, Embase).

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