Global Patient Safety Science Director

Rapport Therapeutics; Boston (MA); Hybrid; USD 245,000 - 270,000; Full time

Job summary

Rapport Therapeutics in Boston is seeking a seasoned safety surveillance leader to guide pharmacovigilance across clinical programs, from early to late phase, with a technology-enabled mindset.

You will lead risk management, develop safety strategies, and oversee DSURs, ICFs, and labeling while collaborating with Medical, Regulatory, Biostatistics, and Clinical Operations teams. Remote and hybrid options available.

Qualifications

• Postgraduate qualification (MD/PharmD/PhD) with 10+ years in drug safety and risk management.
• Experience leading in a matrix environment and with regulatory authorities (FDA/EMA).
• Strong analytical and strategic thinking, problem-solving, and decision-making.
• Excellent organizational and time-management skills.
• Strong interpersonal and communication skills, written and verbal.
• Experience in neuropsychiatric indications.

Responsibilities

• Lead safety surveillance strategy and risk management across clinical programs.
• Accountable for safety sections in protocols, IBs, ICFs, DSURs, RMPs, CCDS, and labeling.
• Participate in Data Monitoring Committees and review safety data.
• Contribute to regulatory submissions and respond to safety information requests.
• Advance signal management using fit-for-purpose tools and AI in safety surveillance.
• Drive process improvements in safety surveillance and data analysis.
• Oversee DSUR production and safety components of study reports.
• Provide medical review for complex IC.

Skills

Analytical thinking

Strategic thinking

Problem-solving

Decision-making

Leadership in matrix environment

Interpersonal skills

Communication skills

Time management

Organizational skills

Education

Postgraduate qualification (MD, PharmD, PhD/MSc in Life Sciences)

Job description

Rapport Therapeutics in Boston is seeking a seasoned safety surveillance leader to guide pharmacovigilance across clinical programs, from early to late phase, with a technology-enabled mindset.

You will lead risk management, develop safety strategies, and oversee DSURs, ICFs, and labeling while collaborating with Medical, Regulatory, Biostatistics, and Clinical Operations teams. Remote and hybrid options available.