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Safety and Risk Management Director
2 months ago
We are seeking a highly experienced and skilled Director of Risk Management and Safety to join our team at ACADIA Pharmaceuticals. The successful candidate will be responsible for overseeing the development and implementation of our risk management system, ensuring compliance with regulatory requirements and industry best practices.
Key Responsibilities- Develop and Implement Risk Management System: Design, implement, and maintain a comprehensive risk management system to identify, assess, and mitigate risks associated with our products.
- Regulatory Compliance: Ensure that our risk management system and plans are compliant with US, EU, and international regulations and guidelines, including ICH and EU GVP.
- Signal Detection and Risk Assessment: Lead the development and implementation of signal detection and risk assessment methods to identify potential safety risks and develop mitigation strategies.
- Project Leadership: Provide project leadership for the development and implementation of epidemiology methods and technology used in the assessment of potential and identified risks.
- Risk Management Planning and Implementation: Ensure that risk management planning and implementation activities are consistent with industry best practices and regulatory requirements.
- Collaboration and Communication: Collaborate with cross-functional teams, including Clinical Development, Medical Affairs, and Regulatory Affairs, to ensure effective communication and coordination of risk management activities.
- Education: Master's Degree in Public Health or related field required. PhD with 4 years of progressive applied epidemiology experience may be considered.
- Experience: 10 years of progressive applied epidemiology experience in a regulated biotechnology or pharmaceutical industry required. Prior experience with Drug Safety and Risk Management strongly preferred.
- Skills: Experience in regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance required. Proficiency in performing data mining activities for analysis of safety data. Excellent written and oral communication skills.
- Competitive Compensation and Benefits: We offer a competitive base salary, bonus, and benefits package, including medical, dental, and vision insurance, 401(k) plan, and employee stock purchase plan.
- Opportunities for Growth and Development: We offer opportunities for professional growth and development, including training and education programs, and a collaborative and dynamic work environment.
