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 Positive 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

📌 Business Partner Manager (Karnataka)
🏢 Astellas
📍 Karnataka