ASSOCIATE MEDICAL DIRECTOR
JOB SUMMARY:
The Medical Reviewer supports the evaluation and monitoring of safety data in accordance with global pharmacovigilance regulations. This role is responsible for the medical review of individual case safety reports (ICSRs), ensuring data quality, consistency, and regulatory compliance. The position contributes to signal detection activities, literature review, and operational pharmacovigilance processes, while collaborating with cross-functional teams and providing support to senior safety physicians. Reporting to the VP of Pharmacovigilance.
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 .
- 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.
- Participate in the preparation and review of aggregate safety reports (e.g., DSUR, PSUR) by contributing case-level insights and data quality checks.
- Assist 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
