About the Role
Leads the development and execution of pharmacovigilance strategies and patient safety initiatives across clinical programs. Ensures compliance with global regulations and contributes to risk management planning and signal detection.
Responsibilities
- Direct the creation and implementation of pharmacovigilance plans for investigational compounds
- Oversee safety database management and case processing in alignment with regulatory standards
- Lead signal detection and safety monitoring activities across clinical trials
- Ensure timely preparation and submission of periodic safety reports
- Collaborate with regulatory teams on safety-related submissions and agency interactions
- Provide safety expertise during clinical development and regulatory inspections
- Guide cross-functional teams on risk assessment and risk mitigation strategies
- Manage relationships with external vendors involved in safety operations
- Develop and maintain safety sections of clinical and regulatory documents
- Support the integration of real-world data into safety monitoring frameworks
- Ensure compliance with international pharmacovigilance regulations and guidelines
- Lead safety training for internal teams and investigators
- Oversee the development of risk evaluation and mitigation strategies (REMS)
- Conduct benefit-risk assessments for ongoing and planned trials
- Serve as safety representative in executive and regulatory meetings
- Drive continuous improvement in safety processes and systems
- Evaluate emerging safety technologies and methodologies
- Coordinate with medical monitoring teams to assess adverse event trends
- Ensure accurate safety data reporting in clinical study reports
- Contribute to due diligence activities for partnerships and acquisitions
Work Arrangement
On-site or hybrid work environment expected; specific details may be discussed during the hiring process.
Team
Part of the global safety and regulatory compliance function, collaborating with clinical, medical, and regulatory teams to manage drug safety across development pipelines.
Why Join Us
- Opportunity to shape the safety strategy of a growing biopharmaceutical company with a focus on innovative therapies
- Work in a science-driven culture that values integrity, collaboration, and patient impact
- Be part of a team advancing novel oncology treatments with global reach
Education & Experience
- MD, PhD, PharmD, or equivalent experience in a related field required
- Minimum of 12 years of progressive experience in pharmacovigilance, including 5 years in leadership roles
Available for qualified candidates requiring authorization.
