Manager, Pharmacovigilance Quality & Compliance

Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

To learn more about us, please visit us at http://www.pharmacyclics.com/

Our Drug Safety, Pharmacovigilance & Epidemiology (DSP&E) department is rapidly growing and we are currently building a new team focused on Quality Systems and Contracts. We are looking for a Manager position to support the PV Quality & Compliance function.

This position is responsible for supporting the PV Quality & Compliance function under PV Operations by efficiently driving the company standards for quality & compliance with internal/external stakeholders (third parties (TPs) to maintain compliance with Health Authority regulations, business partner agreements, and internal PCYC procedures. Activities are in both the clinical trial and postmarketing settings. A TP includes but is not limited to CROs/vendors and business partners with whom DSP&E has a working relationship. This position will provide support with Inspection Readiness activities including managing audits/inspections as needed. The individual supports the business mission of improving patient lives globally through industry leading safety and compliance. In addition, this individual will help shape company culture to help make a remarkable impact on PCYC stakeholders.

Job Responsibilities and Requirements:

Compliance

• Work effectively with PV sub-functions and relevant personnel (internal/external stakeholders) to effectively discuss compliance issues to identify and document root cause, corrective action, and preventative action.

• Escalate broader concerns to PV management and other functions as needed to ensure compliance with regulatory requirements.

•Drive compliance monitoring activities including on-going monitoring of PV Quality & Compliance dashboards and sharing of pertinent information within the organization.

•Lead PV Compliance Joint Forum meetings with internal/external stakeholders.

• Participate in cross-functional discussion on compliance that relate to PV deliverables.

• Monitor metrics to ensure operational efficiency meets established goals/KPIs.

•Support management of DSP&E nonconformance procedures, including identification, investigation, tracking/trending and reporting. Perform investigations and prepare nonconformance documentation.

•Support the development and reporting of DSP&E metrics and monitor efficiency, quality and adherence to regulatory obligations and contractual obligations with TPs. Enhance method of tracking TP compliance to safety agreements.

Quality & Process Improvements

• Drive continuous process improvement initiatives within the function to identify gaps and advise management accordingly.

•Collaborate with DSP&E, QA and other cross functional departments to develop/maintain SOPs/Work Instructions/Forms.

•Maintain a process to ensure TP contracts contain appropriate adverse event reporting language.

•Support PCYC's Quality risk-based program related to DSP&E activities.

Audits/Inspections

• Manage internal and TP process audits. Lead assigned tasks assigned by management

•Collaborate with DSP&E management and Quality Assurance (QA) to prepare for, participate in, and track outcomes (findings) from audits/inspections.

•Contribute to the review of all findings related to drug safety

activities from internal and TP audits/inspections. Ensure action plans (i.e. CAPAs) are developed and implemented when appropriate.

Training

•Coordinate DSP&E document control process with new or revised procedures, ensuring document control and training requirements are fulfilled.

• Mentors and Train team members on PV Quality & Compliance related activities to increase skills and capabilities for organizational effectiveness.

•Maintain SharePoint site and continue to build effective and efficient ways of working.

Education, Experience and Qualifications:

• Master's in life sciences, health/science discipline with 3+ years of relevant PV experience or Bachelor's degree with minimum of 5+ years of experience

•2+ years' experience in vendor management and project management, prior mentoring/training is required

•PharmD or advanced degree preferred.

•Experience managing audits/inspections required

•Experience with Quality Management Systems (TrackWise)

•Project management experience preferred.

•Experience with Project Management Applications preferred

•Experience with Sharepoint preferred

• Experience working with Safety databases (e.g., Arisg, AERS, Argus, etc.) required.

• Proficient with Windows: MS Word, Excel, Power Point; MS Project

•Sound judgment, strong planning and organizational skills, and the ability to get things done. Proactive and flexible.

•Ability to review data and summarize key themes

Equal Opportunity Employer Minorities/Women/Veterans/Disabled