Job Description

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


Responsibilities and Accountabilities:


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.


Support PV contract language for suppliers who may


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


With Business Partner


Manage relationships with business partners


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



Accountability:



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.



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 Sr. Director Business Partner, Management



Peers include BPM team located in across the globe



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



Required Qualifications:



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, FDA, PMDA and local regulations.



Excellent proficiency in English language including speaking and writting.



Strong understanding of contract language and legal terminology, with ability to generate ad interpret complex contract language.



Strong negotiation and communication skills for effective interactions with Business Partners



Understanding of contact compliance and regulatory requirements specific to pharmacovigilance.