Associate Director/Director, Drug Safety & Pharmacovigilance (Quality & Compliance)
Arrowhead Pharmaceuticals
10 hours ago
Remote friendly (San Diego, CA)
United States
Operations
Associate Director/Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance
Responsibilities:
- Provide strategic guidance and leadership to the pharmacovigilance quality assurance team.
- Develop and implement a comprehensive QA strategy aligned with organizational goals.
- Develop/oversee end-to-end PV QA processes and systems to ensure regulatory and internal compliance.
- Provide GVP support for clinical, post-marketing, and commercial activities, protecting patient safety, maintaining data integrity, and supporting Quality Systems.
- Monitor industry trends/regulatory changes/best practices for continuous improvement.
- Monitor vendor KPI metrics and improve CRO/vendor quality.
- Develop, review, and maintain PV QA Standard Operating Procedures (SOPs).
- Manage and develop a team (training, mentoring, performance evaluations).
- Conduct internal audits of PV processes, systems, and data; collaborate with internal/external teams during inspections.
- Develop quality metrics; prepare quality reports for senior management.
- Assess and manage PV-related risks with cross-functional teams.
- Drive continuous improvement; reassess initiatives for effectiveness and adjust strategy.
- Monitor regulatory intelligence affecting PV systems.
- Oversee CAPA development, execution, closure, and escalation as needed.
- Support drug safety/issue management for early issue detection and CAPA effectiveness.
Requirements:
- 10+ years pharmacovigilance/drug safety; 9–10 years in QA/compliance.
- Bachelor’s degree in a related scientific field.
- Strong understanding of global PV regulations, guidelines, and best practices.
- Proven leadership and team management experience.
- Excellent written/verbal communication across cross-functional teams and stakeholders.
- Detail-oriented; strong analytical and problem-solving skills.
- Experience with internal audits and regulatory inspections desirable.
- Proficiency with pharmacovigilance databases and software.
Preferred:
- Advanced degree in pharmacy, life sciences, or related field.
California pay range: $180,000–$230,000 USD
Responsibilities:
- Provide strategic guidance and leadership to the pharmacovigilance quality assurance team.
- Develop and implement a comprehensive QA strategy aligned with organizational goals.
- Develop/oversee end-to-end PV QA processes and systems to ensure regulatory and internal compliance.
- Provide GVP support for clinical, post-marketing, and commercial activities, protecting patient safety, maintaining data integrity, and supporting Quality Systems.
- Monitor industry trends/regulatory changes/best practices for continuous improvement.
- Monitor vendor KPI metrics and improve CRO/vendor quality.
- Develop, review, and maintain PV QA Standard Operating Procedures (SOPs).
- Manage and develop a team (training, mentoring, performance evaluations).
- Conduct internal audits of PV processes, systems, and data; collaborate with internal/external teams during inspections.
- Develop quality metrics; prepare quality reports for senior management.
- Assess and manage PV-related risks with cross-functional teams.
- Drive continuous improvement; reassess initiatives for effectiveness and adjust strategy.
- Monitor regulatory intelligence affecting PV systems.
- Oversee CAPA development, execution, closure, and escalation as needed.
- Support drug safety/issue management for early issue detection and CAPA effectiveness.
Requirements:
- 10+ years pharmacovigilance/drug safety; 9–10 years in QA/compliance.
- Bachelor’s degree in a related scientific field.
- Strong understanding of global PV regulations, guidelines, and best practices.
- Proven leadership and team management experience.
- Excellent written/verbal communication across cross-functional teams and stakeholders.
- Detail-oriented; strong analytical and problem-solving skills.
- Experience with internal audits and regulatory inspections desirable.
- Proficiency with pharmacovigilance databases and software.
Preferred:
- Advanced degree in pharmacy, life sciences, or related field.
California pay range: $180,000–$230,000 USD