Business Manager Jobs at Arrowhead Pharmaceuticals with Visa Sponsorship
Business Manager jobs at Arrowhead Pharmaceuticals drive commercial strategy across its RNA-targeted therapeutic pipeline. The company has a track record of sponsoring international talent in business-facing roles, making it a realistic target if you're on a work visa or transitioning from OPT.
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Get Access To All JobsArrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, 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 Drug Safety & Pharmacovigilance department. This position will lead preparation, delivery, and response to GVP inspections, work closely with 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 PV Quality & Compliance professionals as applicable, 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, post marketing and commercial activities including PV/ safety systems 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.
- Monitor vendor key performance indicator (KPI) metrics and implement measures to enhance the quality of CROs and vendors.
- 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.
- Regularly assess quality and compliance initiatives for effectiveness, outcomes, and relevance, and adjust strategy as needed based on results, risks, and feedback.
- 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.
- Oversee corrective and preventative actions (CAPA) development, execution, closure and, as needed, escalation for CAPAs associated or impacting pharmacovigilance.
- Contribute to drug safety and pharmacovigilance issue management to support early issue detection, CAPA development and completion tracking, and effectiveness assessment for PV systems.
Requirements
- 10 years of experience in pharmacovigilance or drug safety, with 9-10 years in a quality assurance or compliance role.
- Bachelor's Degree in a related scientific field.
- 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.
- Experience in conducting internal audits and managing regulatory inspections is desirable.
- Proficiency in using pharmacovigilance databases and software.
Preferred
- Advanced degree in pharmacy, life sciences, or a related field.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Associate Director/ Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance, 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 Drug Safety & Pharmacovigilance department. This position will lead preparation, delivery, and response to GVP inspections, work closely with 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 PV Quality & Compliance professionals as applicable, 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, post marketing and commercial activities including PV/ safety systems 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.
- Monitor vendor key performance indicator (KPI) metrics and implement measures to enhance the quality of CROs and vendors.
- 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.
- Regularly assess quality and compliance initiatives for effectiveness, outcomes, and relevance, and adjust strategy as needed based on results, risks, and feedback.
- 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.
- Oversee corrective and preventative actions (CAPA) development, execution, closure and, as needed, escalation for CAPAs associated or impacting pharmacovigilance.
- Contribute to drug safety and pharmacovigilance issue management to support early issue detection, CAPA development and completion tracking, and effectiveness assessment for PV systems.
Requirements
- 10 years of experience in pharmacovigilance or drug safety, with 9-10 years in a quality assurance or compliance role.
- Bachelor's Degree in a related scientific field.
- 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.
- Experience in conducting internal audits and managing regulatory inspections is desirable.
- Proficiency in using pharmacovigilance databases and software.
Preferred
- Advanced degree in pharmacy, life sciences, or a related field.
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
California Applicant Privacy Policy
See all Business Manager Jobs at Arrowhead Pharmaceuticals
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Get Access To All JobsTips for Finding Business Manager Jobs at Arrowhead Pharmaceuticals
Frame your degree for specialty occupation
Business Manager roles at pharma companies require demonstrating a direct connection between your degree field and the position. A general business degree may need supplementing with coursework or experience specifically in life sciences commercialization to satisfy USCIS specialty occupation standards.
Target Arrowhead's pipeline-facing business roles
Arrowhead structures Business Manager hiring around its therapeutic programs, not just general commercial functions. Roles tied to specific pipeline assets or therapeutic areas tend to have clearer sponsorship rationale, so align your application materials to the drug programs listed in their open postings.
Search Arrowhead's open roles on Migrate Mate
Filter for Business Manager positions at Arrowhead Pharmaceuticals on Migrate Mate to see which roles are actively hiring and which visa types they've historically supported. This saves you from applying to postings where sponsorship isn't on the table.
Clarify OPT cap-gap timing before your start date
If you're transitioning from F-1 OPT and Arrowhead files an H-1B petition on your behalf, your cap-gap authorization bridges your status until October 1. Confirm your I-20 end date and OPT expiration with your DSO before signing an offer letter so your employment start date aligns.
Understand the PERM timeline for Green Card sponsorship
EB-2 and EB-3 sponsorship through PERM requires DOL to conduct a supervised recruitment process that typically takes 12 to 18 months before a petition can be filed. Raise Green Card intent early in offer negotiations so Arrowhead's immigration counsel can build the timeline into your onboarding plan.
Verify TN eligibility before accepting the offer
Canadian and Mexican nationals may qualify for TN status under the Business Analyst or Management Consultant categories, but the role description must match a listed USMCA profession. Have Arrowhead's immigration team review your job duties against the TN classification before your offer letter is finalized.
Frequently Asked Questions
Does Arrowhead Pharmaceuticals sponsor H-1B visas for Business Managers?
Arrowhead Pharmaceuticals has sponsored work visas for business-facing roles, and Business Manager positions can qualify for H-1B visa sponsorship when the role meets USCIS specialty occupation criteria. Your degree field must align directly with the job duties. Because Arrowhead operates in a highly specialized therapeutic area, roles tied to specific pipeline programs tend to present the strongest specialty occupation argument.
How do I apply for Business Manager jobs at Arrowhead Pharmaceuticals?
You can browse and apply for Business Manager openings at Arrowhead Pharmaceuticals through Migrate Mate, which surfaces roles with confirmed visa sponsorship history. When applying, tailor your resume to reflect commercial experience in biotechnology or pharmaceutical drug development. Arrowhead's postings frequently emphasize cross-functional collaboration across clinical, regulatory, and commercial teams, so highlight experience working in matrix organizations.
Which visa types are commonly used for Business Manager roles at Arrowhead Pharmaceuticals?
Arrowhead has sponsored employees through H-1B, F-1 OPT, F-1 CPT, TN visa, and Green Card pathways including EB-2 and EB-3. F-1 OPT is typically the entry point for recent graduates, with H-1B sponsorship following if the role qualifies. TN visa is available to Canadian and Mexican nationals whose job duties map to an eligible USMCA profession. Green Card sponsorship through PERM is a longer-term path that requires employer initiation.
What qualifications does Arrowhead Pharmaceuticals expect for Business Manager roles?
Arrowhead typically looks for candidates with a bachelor's degree or higher in a field related to business, life sciences, or a combination of both. Relevant experience in pharmaceutical or biotech commercial functions, including market access, product launch, or strategic planning, is commonly expected. For USCIS purposes, the stronger your degree-to-job-duty alignment, the more straightforward the sponsorship case.
How long does the visa sponsorship process take when joining Arrowhead Pharmaceuticals as a Business Manager?
Timeline depends heavily on the visa type. H-1B petitions have an April 1 filing window with an October 1 employment start date, so planning needs to start months in advance. TN status for Canadian nationals can be obtained at the port of entry with same-day processing. Green Card sponsorship through PERM typically spans 18 to 36 months from initiation to I-140 approval, and is usually initiated after you've been employed for a period.