Full-Time

Sr. Manager

Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals

201-500 employees

RNAi-based gene-silencing therapeutics

Biotechnology

$150,000 - $190,000

Competitive salaries, Excellent benefit package

Senior

San Diego, CA, USA

Required Skills
Communications
Quality Assurance (QA)
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%
Responsibilities
  • Provide strategic guidance and leadership to the pharmacovigilance quality assurance team
  • Develop and implement a comprehensive quality assurance strategy aligned with organizational goals
  • 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

Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals

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Arrowhead Pharmaceuticals stands out in the biopharmaceutical industry through its focused application of RNA interference (RNAi) mechanisms to develop targeted therapies for genetic diseases, exemplified by its candidate plozasiran aimed at reducing ApoC3 protein levels to manage severe hypertriglyceridemia. The company's proprietary TRiM platform demonstrates a competitive edge by enabling tissue-specific gene silencing, which has shown promise in early clinical trials, such as the AROAPOC3-2001 study, to improve lipid levels safely and effectively. Arrowhead's approach to drug development not only streamlines manufacturing and potentially reduces costs but also positions the company as a leader in RNAi therapeutics, with ongoing research that could transform treatment paradigms for patients with lipid disorders.

Company Stage

IPO

Total Funding

$899.9M

Headquarters

Pasadena, California

Founded

2004

Growth & Insights
Headcount

6 month growth

11%

1 year growth

33%

2 year growth

65%