SAFETY MEDICAL DIRECTOR

JOB SUMMARY:

The Safety Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Reporting to VP of Pharmacovigilance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Lead signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information.
• Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings.
• Oversee Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects.
• Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR))
• Identification and management of Urgent Safety Measures with support of cross functional team.
• Overview, and/or author aggregate reports and signal evaluation reports for assigned projects.
• Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics.
• Perform medical review of ICSR
• Oversee and provide strategc direaction to safety scientist, medical reviewers, and pharmacovigilance operations team, including vendor oversight.
• Contribute to the development and continuos improvement of pharmacovigilance systems, including SOPs, work instructions, and business process.
• Ensure compliance with global pharmacovigilance regulations and contribute to inspection readiness, audits, and regulatory inspections.
• Contribute to the development and continuous improvement of pharmacovigilance systems, including SOPs, work instructions, and business processes.
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and external partners to ensure alignment on safety strategies. Docusign Envelope ID: 910F614D-1CEE-8CF4-81A1-D8614E2BB051
• Maintain deep and current knowledge of safety regulations, drug development processes, and therapeutic area science.

EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
• MD with 8-12 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
• Strong understanding of pharmacovigilance regulations in the US and EU.
• Experience in supporting drug safety activities in registrational clinical studies
• Demonstrated skills in scientific analysis and reasoning.
• Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance.
• Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable
• An adaptable, detail-oriented leader with a collaborative spirit who excels at managing high-pressure situations and consistently delivering results within tight timelines