Associate Medical Director

Essential Duties and Responsibilities

• Perform medical review and assessment of individual case safety reports (ICSRs) from clinical trials, post-marketing sources, and literature, including causality assessment and expectedness determination.
• Ensure accuracy, completeness, and medical consistency of adverse event data in compliance with global regulatory requirements and company SOPs.
• Conduct quality control (QC) review of safety cases and support reconciliation activities (e.g., clinical database vs safety database, vendor data reconciliation).
• Support literature screening and review, including identification and assessment of safety-related findings.
• Assist in signal detection activities by reviewing safety data and escalating potential safety signals to senior medical staff.
• Provide medical input into case queries and support follow-up for incomplete or unclear safety information.
• Collaborate with pharmacovigilance operations, data management, and external vendors to ensure timely and accurate case processing.
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and external partners to ensure alignment on safety strategies.
• Support oversight of vendors performing case processing and ensure adherence to quality and compliance standards.
• Assist in preparing and reviewing aggregate safety reports (e.g., DSUR, PSUR) by contributing case-level insights and data quality checks.
• Aid in responding to regulatory authority queries related to safety cases and data accuracy.
• Ensure compliance with internal SOPs, global pharmacovigilance regulations, and inspection readiness activities.
• Participate in audits and inspections by providing support related to case review and data quality.
• Maintain up-to-date knowledge of pharmacovigilance regulations, safety databases, and medical review processes.

Education/Knowledge/Skills/Abilities Required

• MD with 5 or more years of experience in Drug Safety and Pharmacovigilance.
• Basic understanding of global pharmacovigilance regulations (FDA, EMA, ICH guidelines).
• Experience in medical review and assessment of ICSRs, including causality and expectedness evaluation.
• Familiarity with safety databases (e.g., Argus or similar systems).
• Strong attention to detail and ability to ensure data accuracy and consistency.
• Good scientific and clinical judgment with the ability to interpret medical data.
• Effective communication and collaboration skills across cross-functional teams.
• Ability to manage multiple tasks and meet timelines in a fast-paced environment.