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Risk Management and Pharmacovigilance Lead
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.
- Compliance and Regulatory Affairs: 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 detection and assessment of safety signals, and develop and implement risk mitigation strategies to minimize risks.
- Project Leadership: Provide project leadership for the development and implementation of epidemiology methods and technology used in the assessment of potential and identified risks.
- 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.
- Regulatory Submissions: Support regulatory submissions, including Marketing Authorization Applications (MAA), New Drug Applications (NDA), and Biologic License Applications (BLA).
- Risk Evaluation and Mitigation Strategy (REMS): Develop and implement REMS plans for our products, as required.
- Periodic Benefit-Risk Evaluation Reports (PBRERs): Prepare and submit PBRERs for our marketed products, ensuring accurate and logical safety conclusions.
- Safety Analysis and Response: Conduct sound safety analysis and respond to regulatory queries, including PBRER assessment reports.
- Education and Experience: Master's Degree in Public Health or related field required. Targeting 10 years of progressive applied epidemiology experience in a regulated biotechnology or pharmaceutical industry required or PhD with 4 years of progressive applied epidemiology experience.
- Regulatory Requirements and Guidelines: Experience in regulatory requirements and guidelines pertaining to Drug Safety and Pharmacovigilance.
- Data Mining and Analysis: Proficiency in performing data mining activities for analysis of safety data.
- Communication and Interpersonal Skills: Excellent written and oral communication skills, with ability to effectively communicate and defend findings and recommended strategies and activities.
- Project Management: Ability to prioritize and organize work to meet deadlines, with excellent project and time management skills.
- Teamwork and Leadership: Ability to work independently and in a team environment, with ability to serve on multiple interdepartmental teams and act as a team leader when appropriate.
