Full-Time
Sr. Manager
Drug Safety & Pharmacovigilance Quality Assurance
Confirmed live in the last 24 hours
Develops RNAi-based therapies for diseases
Biotechnology
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 specializes in developing RNAi-based therapies using their TRiM platform, which leverages various RNA chemistries for tissue-specific targeting, enabling rapid and durable knockdown of disease-causing genes. The TRiM platform also utilizes ligand-mediated delivery, offering potential advantages such as simplified manufacturing, reduced costs, and improved safety.
Company Stage
IPO
Total Funding
$899.9M
Headquarters
Pasadena, California
Founded
2004
Growth & Insights
Headcount