PV Vendor Oversight & Relationship Manager

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

Responsible for business support of PV vendor managers to ensure well managed execution of the outsourced activities in line with the GPV outsourcing strategy and to ensure timely and high-quality deliverables for outsourced activities.

Contribute to PV Strategy Vendor Oversight and Relationship (VOR) management activities by ensuring well-managed execution of the outsourced activities in line with the PV outsourcing strategy to ensure timely and high quality deliverables for outsourced activities in compliance with regulatory requirements.

Reports to the VOR Principles Lead. Contributes to the successful execution of the global outsourcing strategy and PV Process objectives, supporting the overall PV mission

This role is responsible for the support of PV vendor managers and vendors that provide PV-related services and by providing project management, data analysis, facilitation of the development of supporting documentation e.g., vendor relationship manuals to ensure efficient and effective implementation of all outsourcing activities.

Work extensively with VOR Relationship Managers, PV vendor managers, as well as Vendor personnel, and ensures that vendor(s) align with GPV vision and those outputs directly support the ongoing assurance of the safety profile of Astellas products.

Works with Procurement, Global Contract Office (GCO) and functional SMEs and vendor manager to ensure accurate and timely contracting activities with vendors. Supports vendor invoicing approval process as required by the vendor manager and functional SMEs.

Essential Job Responsibilities:

Principles Team

Contributes to developing and maintaining VM principles/standards/best practices e.g., tools, job aids, templates, transition, playbook, implementation planning and maintenance.

Collaborates with Principles Team lead, the PV COPE team, VOR vendor relationship managers, vendor managers and functional SMEs as applicable to:

• develop QC methods to demonstrate oversight of individual outsourced deliverables/services.

• define, develop, implement, and maintain vendor (K)PIs and SLAs to measure performance in quality, timeliness, and compliance, including financial relevant metrics.

• review of collected metric information and contribute to the identification/implementation of continuous improvement initiatives with the vendor(s), leading to operational efficiency gains without compromising quality and compliance of deliverables.

• monitor (K)PI, SLA and metrics for vendor deliverables and ensure root cause analysis is performed and corrective and preventive measures are developed in case of delivery failures by vendor.

Collaborates with VOR relationship managers, vendor manager and functional SME(s) to:

• Facilitate the writing of vendor governance documentation e.g., vendor relationship manuals, transition plans, recruitment, and training plans, for each vendor as appropriate.

• Project manages vendor governance documentation to ensure initial and updated versions across PV vendors are managed and in a timely manner and collects signatures as appropriate.

Responsible for collaborating with Astellas IS and IM functions to ensure:

• Appropriate level of support is provided to vendors to enable them to perform their contracted activities using Astellas IT systems e.g., LSIT, Citrix, Argus, Litmon.

• Vendor onboarding and appropriate access to Astellas systems.

• That IT related issues are escalated as appropriate and urgently notify to the VM VOR Lead, Principles team lead and Analytics team lead in the event that IT issues are affecting business critical activities.

• The Principles Team lead and VM VOR Lead is notified if IS/IM tickets take longer than agreed documented timelines (SLAs) within IT/IM functions.

Vendor training:

• Collaborates with VOR relationship managers, vendor manager, the functional SME(s), vendor point of contact, MDSO Training Solutions and Learning Management System functions to ensure delivery and documentation of vendor training.

• Collaborates with the functional SME(s) to ensure PV awareness training is delivered to vendor staff.

• Collaborates with the vendor manager, functional SME(s) to ensure adequate training has been delivered to the vendor and provide oversight of training and associated documentation of vendor staff.

• Provide project support as required; participate in relevant meetings, governance related activities to support initiatives of the VOR team.

• Liaise with relevant members of PV / Astellas to ensure goals of VOR are accomplished.

Collaboration

This is a highly interactive and collaborative role; the incumbent will establish and maintain effective collaboration with internal PV stakeholders as well as relevant external stakeholders

• With the PV Operations QMS COPE and Strategy & Planning

• With QA

• With all PV functions who outsource PV work to vendors

• With Astellas IS and IM functions

• With non-PV stakeholders such as:

• GCO, Procurement, Finance, Clinical Development

Quantitative Dimensions:

• Oversees multiple PV vendor relationships across various functions

• Contribute to management of Astellas PV outsourcing budget of approx. $35 million annually

Organizational Context:

These activities have major significance to the PV organization and the company at large, and require in- depth subject matter expertise, strategic thinking, and leadership skills to effectively manage complex operations resulting in high quality, effective and efficient as well as regulatory compliant deliverables.

Reports to the Associate Director Vendor Oversight and Relationship.

Qualifications

Required

• Minimum BA/BS degree in life sciences

• Minimum of 5 years relevant experience in pharmacovigilance or combined PV/RA/QA, and/or clinical development

• Technical expert with extensive knowledge

• Proven track record of business information management, data collection, data compilation and analysis, preparing management dashboards

• Analytical skills

• Ability to recommend enhancements to internal policies, processes, and procedures

• Provide industry perspective, share best practices, benchmark information

• Able to present proposals regarding KPI and metrics to senior management

• Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through

• Excellent oral and written communication skills in English, with an ability to interact with all levels of personnel.

• Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global Able to generate insights and leverage learnings at the individual, team and functional level.

• Able to interpret, execute and recommend changes to established policies and programs

• Able to determine best course of action based on strategic direction

• Strong leadership skills

• Decision making skills

• Negotiation skills

• Independent working -- plans, schedules and arranges own activities to achieve desired results

• Independently manages projects that span across various functions or departments

• Extensive PV knowledge

• Demonstrated experience in a vendor management function

• Experience with budgeting, invoicing, and contract management

Benefits

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Referral bonus program

Category Pharmacovigilance

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans