Senior Manager, Drug Safety

1 day ago

San Diego, California, United States Arrowhead Pharmaceuticals Full time
Job Title: Senior Manager, Drug Safety & PharmacovigilanceJob Summary:

Arrowhead Pharmaceuticals is seeking a highly skilled and experienced Senior Manager, Drug Safety & Pharmacovigilance to join our team. The successful candidate will be responsible for overseeing the pharmacovigilance quality assurance team, developing and implementing a comprehensive quality assurance strategy, and ensuring compliance with regulatory requirements.

Key Responsibilities:
  • Develop and implement a comprehensive quality assurance strategy aligned with organizational goals
  • Provide strategic guidance and leadership to the pharmacovigilance quality assurance team
  • Develop/oversee execution of (end-to-end) PV QA processes and systems to ensure compliance/alignment with regulatory requirements and internal policies/procedures
  • Proactively provide Good Pharmacovigilance Practice (GVP) support for clinical and commercial activities to protect patient safety and well-being, maintain data integrity, and support implementation of Quality Systems
  • Monitor industry trends, regulatory changes, and best practices to ensure continuous improvement of quality assurance processes
  • Lead the development, review, and maintenance of Standard Operating Procedures (SOPs) for pharmacovigilance quality assurance activities
  • Ensure that SOPs are consistent with current regulations, guidelines, and industry standards
  • Manage a team of quality assurance professionals, including training, mentoring, and performance evaluations
  • Foster a collaborative and high-performance work environment to achieve departmental objectives
  • Conduct regular internal audits of pharmacovigilance processes, systems, and data to ensure compliance with regulatory requirements
  • Collaborate with internal audit teams and external partners during regulatory inspections and audits
  • Develop and implement key quality metrics to assess the effectiveness of pharmacovigilance processes
  • Prepare and present quality assurance reports to senior management, highlighting trends, issues, and opportunities for improvement
  • Collaborate with cross-functional teams to assess and manage risks related to pharmacovigilance activities. Identify areas of potential risk and implement strategies to mitigate them proactively
  • Drive continuous improvement initiatives to enhance the efficiency and effectiveness of pharmacovigilance quality assurance activities
  • Engage with stakeholders to solicit feedback and implement process enhancements
  • Monitor regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact PV system
Requirements:
  • Degree in pharmacy, life sciences, or a related field
  • Minimum of 8 years of experience in pharmacovigilance or drug safety, with 8-10 years in a quality assurance or compliance role
  • Strong understanding of global pharmacovigilance regulations, guidelines, and industry best practices
  • Proven experience in leading and managing teams, including demonstrated leadership skills and the ability to mentor and develop staff
  • Excellent communication skills, both written and verbal, with the ability to interact effectively with cross-functional teams and external stakeholders
  • Detail-oriented with strong analytical and problem-solving capabilities
  • Proficiency in using pharmacovigilance databases and software
  • Travel 30%
Preferred:
  • Experience in conducting internal audits and managing regulatory inspections
California Pay Range:

$150,000—$180,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.All applicants must have authorization to work in the US for a company.California Applicant Privacy Policy

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