Job Overview: Review, assess, and process safety data and information from various sources.
Distribute reports/data to internal and external parties following applicable regulations, SOPs, and internal guidelines under the guidance of senior team members.
This role will be primarily responsible for Adverse Events (AEs) Intake. Essential Functions:
Complete assigned training on time.Process safety data per regulations, SOPs, and project requirements.Perform pharmacovigilance activities, with a focus on collecting and tracking adverse events (AEs), determining event status, database entry, coding AEs and products, writing narratives, and literature activities.Meet quality, productivity, and delivery standards.Ensure compliance with project processes and activities.Read and acknowledge necessary SOPs and customer SOPs.
Ensure timely execution and documentation of required training.Create, maintain, and track cases as per project plan.Identify and report quality issues to senior team members.Demonstrate problem-solving capabilities.Liaise with project management, clinical, data management teams, and healthcare professionals to address project issues.May liaise with clients regarding day-to-day case processing activities.Mentor new team members if assigned.Attend project team meetings and provide feedback to the operations manager.Perform other duties as assigned.Ensure 100% compliance with all people practices and processes.Conduct medical reviews of non-serious AEs and ADRs as needed.Qualifications:
Bachelor's degree in life sciences or related field with relevant experience preferred.Attention to detail, organizational, and communication skills.Proficiency in Microsoft Office and web-based applications.Ability to multi-task, meet deadlines, and adapt to changing demands.Team player with strong interpersonal skills.Flexibility to work on National Holidays.
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