Position Overview

The Senior Medical Director, Drug Safety and Pharmacovigilance provides medical leadership for global safety activities across clinical development and marketed products. This position partners with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Clinical Operations and Quality to ensure patient safety throughout the product lifecycle while supporting global regulatory submissions and benefit risk decisions.

Key Responsibilities

• Lead the global safety strategy for assigned development and commercial products.
• Serve as the Medical Safety Lead for clinical development programs from early development through post marketing.
• Provide medical review of individual case safety reports and emerging safety issues.
• Lead signal detection, signal evaluation and benefit risk assessments.
• Review and approve safety sections of protocols, Investigator Brochures, Clinical Study Reports and informed consent documents.
• Author and review aggregate safety reports including DSURs, PSURs, PBRERs and PADERs.
• Develop and maintain Risk Management Plans and other regulatory safety documents.
• Chair or participate in Safety Review Committees and cross functional governance meetings.
• Collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics and Quality.
• Support global regulatory submissions and respond to health authority questions from agencies such as the FDA and EMA.
• Provide oversight of pharmacovigilance vendors and CRO partners.
• Ensure compliance with ICH guidelines and global Good Pharmacovigilance Practice requirements.
• Mentor junior physicians and safety scientists while contributing to departmental strategy.

Required Qualifications

• Medical Doctor degree.
• At least 8 to 10 years of experience in the pharmaceutical or biotechnology industry.
• Extensive experience in Drug Safety, Medical Safety or Pharmacovigilance.
• Experience supporting products from Phase I through post marketing.
• Strong expertise in signal detection, safety surveillance, benefit risk assessment and medical review.
• Experience preparing or reviewing DSURs, PSURs, PBRERs, PADERs and other aggregate safety reports.
• Experience interacting with global health authorities including the FDA and EMA.
• Strong leadership, communication and cross functional collaboration skills.

Preferred Qualifications

• Experience in Oncology, Immunology, Rare Diseases or Neurology.
• Experience supporting global product launches.
• Experience with Argus Safety or a comparable safety database.
• Experience leading inspection readiness activities.

Core Competencies

Drug Safety, Pharmacovigilance, Signal Detection, Safety Surveillance, Benefit Risk Assessment, Aggregate Reporting, Regulatory Strategy, Global Patient Safety, Cross Functional Leadership, Executive Communication.

Why Join

Opportunity to shape global safety strategy for innovative therapies while working with cross functional leaders in a collaborative environment focused on scientific excellence and patient safety.