Sr. Manager, Drug Safety & Pharmacovigilance Quality Assurance - Arrowhead Pharmaceuticals
San Diego, CA
About the Job
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Senior Manager of Drug Safety & Pharmacovigilance (PV) Quality, is a key role and is responsible for oversight of Drug Safety & PV quality, compliance, and alliance management activities, thus always promoting inspection readiness and maintaining a robust global compliance program within the Quality Assurance department. This position will lead preparation, delivery, and response to GVP inspections, work closely with PV and QA to ensure Patient Safety input to GCP, GVP, GMP inspections, support issue reporting and CAPA development, monitor quality and compliance. The successful candidate will provide strategic direction, manage a team of quality assurance professionals, and collaborate with cross-functional teams to enhance the safety and quality of pharmaceutical products.
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
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
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.