Director/Senior Director, Pharmacovigilance and Drug Safety (Safety Scientist)

Xenon

Job Overview

Location

Boston

Job Type

Full-time

Full Job Description

📋 Description

• Lead proactive signal detection, benefit-risk analyses, and safety monitoring/reporting for Xenon’s clinical and marketed neuroscience products across all development stages.
• Author and manage global aggregate safety reports including IND/NDA Annual Reports, PADER, DSUR, PSUR, PBRER, and ad-hoc regulatory responses in full compliance with FDA, EMA, and ICH guidelines.
• Collaborate with cross-functional teams—Clinical Development, Regulatory Affairs, Biostatistics, Clinical Data Management, Non-clinical Safety, and Medical Affairs—to compile accurate and timely safety data for regulatory submissions and internal reviews.
• Review and contribute to safety sections of critical documents including Study Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), SAPs, DSMB charters, and product labeling.
• Perform detailed review of serious adverse events and expedited individual case safety reports to ensure data integrity and enhance aggregate safety analysis quality.
• Analyze and communicate safety trends, signals, and emerging concerns from clinical and post-marketing sources, ensuring timely escalation and response to Health Authorities.
• Author safety signal assessment reports in collaboration with Safety Physicians and contribute to Safety Governance and Safety Risk Management Team (SRMT) meetings.
• Support development of risk management strategies, including Risk Management Plans (RMPs) and risk mitigation activities, aligned with global regulatory expectations.
• Review and provide input to Safety Monitoring Plans (SMPs) and other safety-related clinical trial documentation.
• Maintain up-to-date safety profiles for all assigned investigational and marketed products through continuous monitoring and data interpretation.
• Prepare for and support regulatory inspections by ensuring audit readiness and providing requested safety documentation and data.
• Write, maintain, and update Standard Operating Procedures (SOPs) to ensure compliance with global pharmacovigilance regulations and internal quality standards.
• Respond to ad-hoc information requests from regulatory authorities and internal stakeholders with scientifically sound, evidence-based analyses.
• Participate in cross-functional safety governance processes, presenting safety data and contributing to benefit-risk assessments for Xenon’s pipeline assets.
• Ensure adherence to company policies including Code of Business Conduct and Ethics, and foster a culture of compliance and quality within the Pharmacovigilance team.
• Train and mentor team members and cross-functional colleagues on pharmacovigilance processes, regulatory requirements, and safety reporting standards.
• Utilize pharmacovigilance databases (e.g., Argus Safety) and signal detection tools to analyze safety data and support decision-making.
• Apply MedDRA coding expertise to accurately classify adverse events and ensure consistency across global reporting.
• Demonstrate strong technical writing, data visualization, and statistical interpretation skills to translate complex safety data into clear, concise regulatory and scientific communications.
• Manage multiple competing priorities under tight deadlines while maintaining high standards of accuracy, timeliness, and regulatory compliance.
• Work in a hybrid model based in Xenon’s Needham, MA office with a minimum of two onsite days per week.

🎯 Requirements

• Health Care Professional degree (e.g., RN/BSN/MSN, NP, PharmD) with 9+ years (Director) or 12+ years (Senior Director) of pharmaceutical industry experience in drug safety and pharmacovigilance
• Master’s degree preferred for Director role; required for Senior Director role
• Proven experience leading authorship of DSUR, PADER, PBRER, and other aggregate safety reports
• Demonstrated expertise in FDA and EMA pharmacovigilance regulations and ICH guidelines
• Hands-on experience with Argus Safety Database and signal detection tools
• Strong understanding of MedDRA coding, clinical trial phases, and post-marketing safety surveillance

🏖️ Benefits

• Base salary, target bonus, and stock options
• Comprehensive medical, dental, and vision insurance
• Short- and long-term disability, life insurance, and accidental death & dismemberment coverage
• Employee Assistance Program and travel insurance
• Retirement savings program with company matching contributions
• Generous vacation, personal, and sick days, plus end-of-year company shutdown
• Tuition Assistance program for advanced degrees
• Expanding Training, Learning & Development program

Skills & Technologies

REST

Senior

Remote

Degree Required

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Xenon

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About Xenon

Xenon is a leading provider of advanced data analytics and artificial intelligence solutions. The company specializes in developing and implementing cutting-edge technologies that help businesses unlock the full potential of their data. Xenon's offerings include predictive modeling, machine learning algorithms, and data visualization tools, all designed to drive informed decision-making and operational efficiency. They serve a diverse range of industries, including finance, healthcare, and retail, empowering clients to gain deeper insights, optimize performance, and achieve strategic business objectives. Xenon is committed to innovation and delivering tangible value through data-driven strategies.

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