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 .

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:

This role is accountable for accurate and timely execution, distribution and maintenance of all Astellas Pharmacovigilance Agreements (PVAs) with Business Partners including, but not limited to, safety data exchange agreements and Good Pharmacovigilance Practice (GVP) agreements to ensure compliance with worldwide regulatory requirements and Astellas policies. This role contributes to the development and successful implementation of the Business Partner Management (BPM) 1 -3 year strategic plan. The incumbent is the main point of contact for Astellas business development both within headquarters and in the affiliates and is responsible to establish and maintain good business relations with Astellas' business partners. The timely execution and implementation has a direct impact on Astellas compliance.

Essential Job Responsibilities:

Within GPV/Affiliates:

  • Identify, develop, negotiate, and finalize (or terminate) complex PV Agreements with all relevant business partners in a timely fashion; ensure timely re-negotiation, updating and finalization (or termination) of complex PV Agreements according to Astellas procedures or change in requirements

  • Create/Maintain Agreements with Astellas Affiliates

  • Act as liaison to PV functions (PVP, GSS, GMS, Affiliate Management, and QMS) to assess feasibility of proposals from business partners resulting from license agreements, acquisitions, divestitures, or collaborations to ensure ability to comply with obligations as stated in the agreement; distribute finalized PV Agreements with GPV functions to allow compliance to obligations.

  • Ensure accurate information is available for GPV, affiliates and other relevant functions during PVA development.

  • Support QMS in inspection/audit preparation, timely execution and submission of responses to findings and for timely planning, creation, submission, implementation, maintenance and follow-up of corrective and preventive action plans related to GBPM.

  • Ensure accurate information is maintained in the tracking tools for PVAs.

  • Ensure adequate local and global procedures are available and adhered to for PVA development and maintenance; Maintain templates and procedures in line with regulations and Astellas policies.

  • Support the supervisor in Training and mentoring of new staff/contractors and other departments ensuring the relevant safety staff have all necessary knowledge and expertise to execute their responsibilities.

  • Escalate issues appropriately.

  • Maintains an up-to-date knowledge of PV regulations and guidelines.

  • JP Only: Act as Liaison to support GVP operations including the launch of product, transfer of

  • approvals, and management of control drug in clinical trial agreement.

Within Astellas:

  • Manage relationships with key stakeholders outside of GPV (CRQA, Business Development, Legal, etc.) to enable timely identification of commercial agreements requiring PVA development and promote compliance to corporate safety standards; may include conducting due diligence.

  • Liaise with CRQA regarding audit strategy for business partners.

  • In Japan office, liaise with other functions as appropriate to support the launch of products, product approval transfer, and clinical trial agreement.

With Business Partners:

  • Manage relationships with business partners.

  • Act as liaison with business partner for compliance investigations, audits or inspections.


Accountable for negotiating, finalizing and maintaining PVAs on behalf of the GPV organization in a timely manner to ensure compliance to regulations. Implementation of PVAs has a significant impact on Astellas' compliance to regulatory requirements and relationships with Business partners therefore the risk of this position is high. Non-compliance may have a significant impact on financial budget.

Project activities:

Independently manages projects to deliver results within agreed upon timelines; works with cross-functional teams to establish and implement PVA strategy Leads global and/or large project teams in order to improve efficiency and/or quality deliverables; design project plan, activities, stakeholders, risks, mitigation strategies, timelines, etc.

Quantitative Dimensions:

  • May have responsibility for assigning tasks/work to other team members.

  • Maintenance of approximately 75-100 PVA

  • Primary point of contact for 25-50 business partners

  • Failure to meet contractual obligations can have financial consequences for Astellas

Organizational Context:

  • This position reports to Associate Director, Director or Sr. Director Business Partner Management.

  • This position may oversee Managers or Coordinators, as applicable.

  • Peers include Sr. Managers or Managers located in the EU, JP or US offices.

  • This role has critical and frequent interactions with senior management from license partners, Astellas' business development, legal, EU QPPV, JP QPPV, CQA, affiliate DSOs, Affiliate general managers.



  • Minimum BA/BS degree. 6+ years’ experience in the pharmaceutical industry with at least 6 years in Pharmacovigilance.

  • Significant and demonstrable working knowledge of pharmacovigilance regulations and guidelines, including ICH and EU regulations.

  • Comprehensive knowledge of global regulations including 21 CFR Parts 314 and 211, EU

  • Good Vigilance Practice Modules, MHRA Practice Guide, PMDA/Green Book and other relevant regulatory guidance relating to Pharmacovigilance regulations across the product development through commercialization spectrum.

  • Able to chair meetings, present orally and interact with external business partners.

  • Ability to establish standards and to interface and influence across multiple departments, levels of management, cultures and functions.

  • Effective project and program management skills.

  • Effective interpersonal, communication (oral and written), negotiation, facilitation, and influencing skills within a broad matrix. Ability to synthesize and convey complex data or concepts in an understandable way.

Problem solving skills:

  • Makes independent decisions on complex problems. Can find solutions to resolve negotiation failures; identifies risks and provides mitigation plans.

  • Able to manage multiple projects simultaneously and has excellent time management skills

  • Accurate and attention to detail; creative and innovative thinking

  • Able to maintain composure in stressful and/or difficult situations

  • Able to contribute to strategic decision-making and high-level thinking


  • Self-motivated, takes initiative, makes decisions, and works independently with minimal supervision.

  • Leads project teams with minimal intervention from management

  • Supervises and/or mentors the quality of the deliverables of junior members

  • Receives constructive feedback from supervisor and others to improve behaviors to align with Astellas Core Values and Competencies


  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

  • 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 PV Strategy

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans