Associate Medical Safety Director

About the role

We are seeking an Associate Medical Safety Director to provide medical expertise on pharmacovigilance services across divisions. The role supports safety evaluation on clinical trials and post‑marketing projects, ensuring regulatory compliance and patient safety.

Key responsibilities

• Perform medical review and clarification of trial‑related adverse events (AEs) and post‑marketing adverse drug reactions (ADRs), including narrative writing, coding, expectedness, seriousness, causality and summary preparation.
• Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases in line with regulatory requirements.
• Serve as internal consultant to pharmacovigilance case processing teams, providing aggregate safety reviews and clinical data oversight.
• Review and edit regulatory safety documents such as IND Annual Reports, EU Periodic Benefit‑Risk Evaluation Reports, US Periodic Reports, Development Risk Management Plans, and label submissions.
• Provide medical oversight for Data Safety Monitoring Board meetings, safety monitoring committees, and integrated safety summaries.
• Conduct medical safety review of protocols, investigative drug brochures, and case report forms to ensure appropriate safety content and data capture.
• Act as Global Safety Physician or backup on assigned projects, ensuring coverage of all medical safety deliverables within contractual timelines.
• Offer 24‑hour medical escalation support for pharmacovigilance projects and stay current with industry regulatory developments.

Required profile

• Medical degree (MD) from an accredited, internationally recognized medical school.
• Minimum 7 years of clinical practice experience, preferably with exposure to signal management and clinical trial documentation.
• Demonstrated experience in pharmacovigilance, adverse event assessment, and regulatory safety reporting.
• Ability to work independently and collaboratively with cross‑functional safety teams.

Required skills