Job Description

The Role
Reporting to a senior leader within Drug Safety and Pharmacovigilance, the Senior Director is responsible for supporting the development and implementation of a comprehensive risk management system encompassing risk detection, assessment, and minimization for investigational and marketed products.
This role oversees risk management plan activities, including signal tracking and maintenance, responses to ad hoc Health Authority requests, and the planning and preparation of aggregate safety reports such as DSURs, PADERs, and PBRERs across the company's portfolio. Key Responsibilities
Safety Signal Detection, Evaluation, and Management

• Partner closely with Safety Physicians to analyze potential safety issues, including signal detection, evaluation, and management.
• Collaborate proactively with study teams, cross-functional stakeholders, and external partners to apply scientific and analytical expertise within relevant therapeutic areas.
• Contribute to signal detection and data mining activities using internal and external data sources.
• Support evaluation of potential safety issues and preparation of quality risk assessment reports.

Risk Management and Safety Planning

• Coordinate and develop Risk Management Plans across programs in collaboration with multiple internal and external stakeholders.
• Support patient safety evaluation and development of Safety Management Plans.

Safety Governance, Meetings, and Reporting

• Contribute to safety governance activities, including preparation of reports, meeting materials, and minutes; tracking action items; and participating in discussions of patient safety topics.
• Manage and support authoring of aggregate safety reports (e.g., DSURs, PBRERs, PADERs) in close collaboration with clinical, medical writing, and operational teams.

Processes, SOPs, and Ways of Working

• Contribute to the development and maintenance of SOPs, work instructions, templates, and related communications supporting pharmacovigilance and risk management.
• Help ensure consistent, scientifically sound global PV processes and ways of working across teams.

Analytics and Tools

• Develop proficiency with safety data visualization and analytics tools (e.g., Spotfire or similar platforms).
• Contribute to scenario planning, strategic analysis, portfolio prioritization, and forecasting activities within Drug Safety and Pharmacovigilance.

Leadership and Training

• Provide people leadership and/or mentoring to Safety Scientists.
• Support onboarding and ongoing training of new team members in PV practices and therapeutic area knowledge.

Core Competencies

• Design and implement global risk management frameworks for pharmaceutical products.
• Translate complex safety data into actionable clinical insights.
• Leverage visualization and analytics tools for proactive safety surveillance.
• Influence cross-functional and multidisciplinary teams to prioritize patient safety.
• Demonstrated ability to collaborate, build relationships, and influence internally and externally.

Qualifications

• Advanced degree in a medical or healthcare-related discipline (e.g., MD, PharmD, RN, PhD).
• 9+ years of experience in Drug Safety/Pharmacovigilance within pharmaceutical, biotechnology, or regulatory environments.
• Strong knowledge of U.S. and EU drug safety regulations, including CIOMS and ICH guidelines.
• Experience conducting medical safety assessments and overseeing safety surveillance activities.
• Experience managing safety data from clinical trials, literature, and post-marketing sources.
• Experience preparing responses to Health Authorities and supporting IND/NDA submissions and regulatory interactions.
• Experience developing and maintaining Reference Safety Information, Investigator's Brochures, Company Core Data Sheets, and product labeling.
• Excellent written, verbal, and presentation skills.

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