Manager/Senior Manager (Quality Systems and Contracts, Drug Safety and PV Operations)

At Pharmacyclics, our every effort is directed to bringing new therapies to life: treatments that help people return to the lives they love as quickly and easily as possible. We believe there is nothing more powerful than giving back in this way. We believe there is nothing more valuable than turning hope into reality and allowing people to focus on the splendor in every day. This is what we call the magic of normal—and we want this for as many people as possible.

This position is responsible for managing DSP Operations Quality Systems and Contracts by collaborating with internal stakeholders and external Third Parties (TPs) to maintain a risk-based program. Activities are in both the clinical trial and post-marketing settings. A TP includes but is not limited to CROs/vendors and outside partners (e.g., License Partners) with whom DSP has a working relationship.

• Establish and maintain optimal relationships with internal and external stakeholders.
• Establish a framework for the Quality Systems function within DSP to include controlled document management, audit-preparedness, compliance monitoring/reporting and contracts.
• Collaborate with DSP management and Quality Assurance (QA) to prepare for, participate in, and track outcomes (findings) from audits/inspections.
• Oversee the review of all findings related to drug safety activities from audits/regulatory inspections (internal company and PV TPs). Ensure CAPAs are developed and implemented when appropriate.
• Support the development and reporting of DSP metrics and monitor efficiency, quality and adherence to regulatory and contractual obligations with TPs.
• May conduct monitoring visits of PV TPs.
• Establish and maintain a process to ensure TP contracts contain appropriate adverse event reporting language.
• Collaborate with DSP, QA and other departments to develop quality system-related SOPs.
• Establish and manage DSP nonconformance procedures, including identification, investigation, tracking/trending and reporting. Perform investigations and prepare nonconformance documentation.
• Work with TPs to manage cross-company compliance/nonconformance procedures.
• Contributes to the evaluation and implementation of new systems and tools that enhance DSPs PV Operations and Quality Systems.
• Contributes to process improvement and educational initiative.
• Perform other activities as directed by management.

• Bachelor’s degree in life sciences or other relevant discipline preferred.
• 3-5 years Pharmacovigilance quality system experience in the post marketing setting or equivalent experience.
• Working knowledge of domestic and international pharmacovigilance regulations. Knowledge of HIPAA preferred.
• Excellent interpersonal skills.
• Ability to work effectively on multiple projects under tight timelines and able to adapt and prioritize as needed.
• Experience interacting with TPs preferred.
• Demonstrated ability to manage cross-functional, complex projects and to operate in a cross-functional team environment.
• Safety database (Argus, ArigG or similar platforms) and quality computer systems experience preferred.
• Strong project management skills preferred.
• Excellent MS Word, Excel and PowerPoint skills.
• Excellent written and oral communication skills.
• Excellent analytical and problem-solving skills.