Pharmacovigilance Associate Jobs in Kaisha Lifesciences

Job Requirements

• Serve as the primary point of contact for assigned cases, responding to inquiries from internal and external customers in a timely and professional manner
• Review and process adverse event reports, ensuring accuracy and completeness of data entered into the safety database
• Perform initial case assessments to determine the severity, expectedness, and causality of reported events
• Conduct follow-up activities with reporters as needed to obtain additional information or clarification
• Prepare cases for review by Medical Reviewers, providing all relevant documentation and supporting materials
• Escalate severe cases to the appropriate level within the organization through company procedures
• Monitor literature for new safety information on assigned products
• Generate periodic reports summarizing safety data for trusted products
• Assist with special projects as needed, such as audits, inspections, and process improvement initiatives
• Attend and participate in team meetings, training sessions, and conference calls
• Maintain up-to-date knowledge of applicable regulations and guidelines
• Adhere to all company policies and procedures

Work Experience

• Bachelor's degree in a scientific discipline
• 1-2 years of experience in the pharmaceutical or biotech industry, with some exposure to pharmacovigilance
• Excellent written and verbal communication skills
• Strong organizational skills and attention to detail
• Ability to work independently and as part of a team
• Proficient in Microsoft Office applications