Director, Medical Safety

### **Responsibilities**

• Conduct medical review of clinical trial and post-marketing safety data, including adverse events (AEs), adverse drug reactions (ADRs), coding, causality, expectedness, seriousness assessments, and benefit-risk evaluations.
• Provide medical oversight and review of safety documentation, including narratives, aggregate reports, annual and periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures, and case report forms.
• Support safety governance activities, including Data Safety Monitoring Boards, Safety Monitoring Committees, medical information escalations, pharmacovigilance oversight, and 24-hour medical support as required.
• Serve as Global Safety Physician, project lead, or medical safety advisor, ensuring quality, compliance, operational delivery, training, stakeholder communication, and timely completion of deliverables.
• Present safety findings and provide expert medical consultation to clients, internal teams, and cross-functional stakeholders.
• Lead and develop medical safety teams through people management, workload planning, performance management, mentoring, training, resource allocation, and succession planning.
• Oversee financial, operational, and quality performance of assigned projects, ensuring appropriate resourcing and regulatory compliance.
• Contribute to business development activities, including proposals, budgeting, bid defenses, client presentations, strategic planning, and service-line growth initiatives.
• Represent the Medical Safety function internally and externally, maintaining key stakeholder relationships and supporting organizational objectives.
• Drive continuous improvement through awareness of industry, regulatory, and pharmacovigilance developments, and undertake special projects as required.
• Provide global medical safety and pharmacovigilance oversight across clinical development and post-marketing programs.
• Lead medical review of safety data, regulatory reports, risk management strategies, and benefit-risk assessments.
• Manage medical safety projects, ensuring quality, compliance, stakeholder engagement, and on-time delivery.
• Lead, develop, and resource teams of physicians and medical safety professionals globally.
• Support business growth through client engagement, proposals, strategic initiatives, and service-line leadership.

• Strong knowledge of global pharmacovigilance, clinical research, safety reporting, Good Clinical Practice (GCP), and applicable regulatory requirements.
• In-depth understanding of clinical development, pharmaceutical research, and medical safety/monitoring activities.
• Proven ability to manage multiple priorities, meet deadlines, and deliver high-quality outcomes in a complex environment.
• Strong consulting, communication, stakeholder management, and relationship-building skills, with the ability to influence clients and cross-functional teams.
• Demonstrated leadership capability, including people management, project oversight, financial accountability, and strategic decision-making.
• Medical degree (MD or equivalent) from an accredited institution, with substantial clinical practice experience and/or pharmaceutical physician experience.
• Significant experience in medical safety, pharmacovigilance, or medical monitoring within the pharmaceutical, biotechnology, CRO, or healthcare industry.
• Current medical licensure (or equivalent professional registration) in the country of practice.