Job Duties and Responsibilities:
- Conduct 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.
- Conduct secondary evaluation of references screened and submitted by primary screeners to the customer’s database.
- Index abstracts from literature and work closely with the manager to provide constructive feedback to primary screeners who fail to report AEs, enhancing the quality of AE reporting.
- Stay updated on new pharmaceutical developments, therapeutic categories, emerging diseases, and modifications in biomedical terminology in the published literature.
- 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:
- Bachelor’s/Master’s 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).
