Responsibilities:

– Conduct the review of all domestic and foreign safety adverse events (SAE) reports for all investigational and post-marketed products to make sure all important SAE elements are provided,

– Ensure consistency in the initial investigator causality assessment of SAE reports and source documentation for completeness, accuracy, and eligibility,

– Draft case narrative for SAE reports and prepare MedWatch, CIOMS, and other forms, as needed,

– Perform quality reviews of completed SAE reports, transmit reports to business partners per timelines in safety data exchange agreements,

– Exercise judgment and apply knowledge of FDA, EMA, and ICH guidelines and product labeling in performing SAE case assessments of expectedness,

– Collaborate with cross-functional teams, Clinical Operations, Data Management, and Biostatistics,

– Analyze metrics for critical drug safety processes to ensure compliance with SOPs and regulatory requirements. Formulate and implement improvements as needed,

– Guide the team with other SAE reporting and Pharmacovigilance Operations,

– Handle all the safety-related issues and potential trends and or signals arising from the review of pre and post-marketed safety data,

– Assist in developing Safety forms, standard operating procedures, and process guidelines,

– Assist in signal detection activities and provide line listings for review,

– Support and participate in audits and inspections, including preparation activities,

– Conduct literature searches to ensure the most current and appropriate literature is cited in the materials and to maintain product expertise,

– Review published scientific literature for ICSRs pertinent to products.

Requirements:

– A bachelor’s degree in Medicine is required,

– At least 3 years of drug safety experience,

– Experience in SAE case processing and working with safety databases,

– Knowledge of MedDRA and WHO Drug coding,

– Proven knowledge of Good Documentation Practices,

– Proficient in MS Office,

– Excellent written and verbal communication skills; fluent in medical terminology,

– Excellent English skills, both written and verbal,

– Good presentation skills,

– Ability to interpret and follow regulatory guidelines,

– Ability to multi-task and balance day-to-day drug safety operations and project work with tight timelines,

– Willing and able to work independently and in a collaborative team setting.