About the Role
Leads the development and execution of drug safety policies and pharmacovigilance activities for global markets. Ensures timely detection, assessment, and reporting of safety data in alignment with regulatory standards.
Responsibilities
- Direct the global pharmacovigilance strategy and safety risk management
- Oversee safety database operations and signal detection processes
- Ensure compliance with international regulatory requirements for drug safety reporting
- Lead inspection readiness and support regulatory audits
- Manage post-marketing safety surveillance and periodic safety update reports
- Collaborate with cross-functional teams on safety aspects of clinical development
- Supervise the preparation and submission of expedited and aggregate safety reports
- Guide benefit-risk assessments for marketed and investigational products
- Lead responses to regulatory agency inquiries related to safety data
- Develop and maintain safety monitoring plans and risk evaluation frameworks
- Oversee vendor performance for outsourced pharmacovigilance activities
- Ensure accurate and timely case processing in line with service level agreements
- Drive continuous improvement in safety operations and systems
- Mentor and develop a team of safety professionals
- Establish safety metrics and performance indicators
- Support product development teams with safety expertise
- Lead safety training programs for internal stakeholders
- Coordinate with legal and compliance on safety-related regulatory obligations
- Manage safety communication strategies including labeling updates
- Evaluate emerging safety signals and recommend risk mitigation actions
- Ensure alignment with corporate quality standards and governance
- Participate in global safety governance committees
- Oversee the implementation of safety-related technology solutions
- Maintain up-to-date knowledge of evolving pharmacovigilance regulations
- Serve as a key safety representative in corporate initiatives
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid work model with flexibility for remote and office-based work
Team
Part of the Global Safety and Regulatory leadership team
Leadership Expectations
- Provide strategic direction for the pharmacovigilance function across all development stages
- Foster a culture of compliance, accountability, and continuous learning within the safety team
- Serve as the primary safety advisor to senior management and regulatory bodies
Global Compliance
- Ensure adherence to pharmacovigilance regulations in the US, EU, and emerging markets
- Oversee the implementation of region-specific safety reporting requirements
- Maintain alignment with evolving international safety standards and guidance
Available for qualified candidates
