About the role
- Supervise, train and mentor a team of literature reviewers and quality checkers, who are responsible for screening the literature articles, extracting the relevant case information, performing the causality and seriousness assessment, coding the adverse events and drugs, and generating the ICSR narratives.
- Manage the identification, review, and reporting of Individual Case Safety Reports (ICSRs) from scientific and medical literature.
- Coordinate with other ICSR teams, pharmacovigilance (PV) functions, medical affairs, clinical operations and external vendors to ensure effective and efficient literature search and review activities, such as defining the search criteria, updating the search strategy, resolving the queries, etc.
- Monitor and report the literature screening and review metrics and performance indicators, such as the number of articles screened, the number of ICSRs identified, the quality and timeliness of the ICSRs, the compliance rate, the productivity, etc.
- Identify and implement process improvements and best practices for literature screening and review, such as optimizing the search strategy, standardizing the review process, enhancing the quality checks, etc.
- Provide support for audits, inspections and CAPAs related to literature screening and review, such as preparing the audit/inspection readiness, responding to the findings, implementing the corrective and preventive actions, etc.
- Years of experience: 8-10 years of relevant experience in PV literature screening and review.
- Required manpower: 1
- Educational qualification: Bachelor's or Master's degree in pharmacy, life sciences or related fields.
- Skills and competencies: Excellent knowledge of PV regulations and guidelines, literature search and review methodologies, ICSR reporting and documentation, adverse event and drug coding, ICSR narrative writing, literature screening and review tools and systems, quality assurance and compliance, team management and leadership, communication and coordination, problem-solving and decision-making, etc.