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. Hybrid work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in hybrid work are encouraged to apply. **Purpose:** In coordination with/or in the absence of the US DSO: + This role is responsible for acting as deputy to the local Drug Safety Officer (DSO) and performing PV activities conducted at the local affiliate by maintaining the operational excellence in PV activities at the local affiliate. + Responsible for supporting the implementation of procedures to ensure compliance with both local and regional PV regulations and Astellas global and regional policies and procedures. + Responsible for monitoring and reviewing the PV activities at the local affiliate level, whilst supporting the oversight of the systematic collection and documentation of Product Safety Information (PSI) and related activities and passing information to all other relevant stakeholders that could include the Health Authorities (HA). + Responsible for the collection of relevant publicly available PV information and use this information to inform relevant people. + Responsible for developing and maintaining professional relationships with relevant external contacts such as governmental bodies and pharmaceutical industry associations, where appropriate and in line with Ethics and Compliance (E&C) requirements and local legislation. + Responsible for ensuring compliance with PV Astellas policies, global, regional (e.g., US) and local laws and guidance. Liaise within the local affiliate and with PV Affiliate Support Function colleagues on matters relating to strategy, management, and compliance that impact PV. **Essential Job Responsibilities:** **Strategy Development and Execution** Supports/contributes to successful implementation of the 1–3-year Global, Regional Affiliate Management (AFM) and local specific objectives and plans as part of the overall PV strategy and plans. Deputy DSO is responsible for: **General Department** + Drive a PV mindset across the US group of companies and non-PV functions. + Support implementation of processes and activities in which the PV department can contribute to the compliance, efficiency, and overall effectiveness of the local affiliate. + Support implementation of new (local) initiatives, management tools or processes in cooperation with PV AFM Function. + Provide support in ensuring that all PV local affiliate staff have access to the necessary tools and systems. + Responsible that processes, procedures, and PV files are well documented in an up-to-date and complete archive i.e., ‘audit/inspection ready’ status. + Provides input for capacity and resource management for the PV department at the local affiliate. + Manage local business partners and coordinates the required contribution from the local business partners to the PV system and requirements, if applicable. **Management of Product Safety Information** + Ensure that PSI (Adverse Events) received from all sources (e.g., literature search, Market Research, Patient Support, Digital Media) by the local affiliate are collected, translated, and forwarded to designated Regional/Global PV Headquarters (HQ), in compliance with required timelines, quality guidelines and standards, as applicable. + Ensure the filing, storage and archiving of PSI in the electronic archive or paper-based archive, as applicable, and in accordance with PV regulations and with Astellas policies and procedures. + Maintain awareness of the system(s) in place for the handling and tracking of data that may contain PSI e.g., Medical Information Enquiries (MIE) and Product Quality Complaints (PQC). + Perform reconciliation activities with other Astellas operating unit systems (e.g., MI and TrackWise for Quality Assurance) and contractual partners, as applicable. + Monitor and manage vendors to which PV activities have been outsourced (as pertains to local regulations). **PV Quality and Compliance** + Coordinate and conduct all PV activities in alignment with Regulatory requirements and internal Astellas procedures to ensure full compliance. + Support implementation of relevant updates to PV regulations (including maintenance reporting rules matrix), within the required timeline. Communicate any changes to PV AFM, EU-QPPV, the PV Regional HQ Office and/or other local business functions, as applicable. + Ensure compliance with local and regional PV regulations and Astellas policies/procedures and take corrective and/or preventive actions, as appropriate and required. + Support due diligence of potential new product acquisitions/local country licensing agreements, if applicable. **Maintenance of PV System and Oversight Responsibilities** + Provide input for the Pharmacovigilance System Master File (PSMF) regarding the local affiliate. + Ensure the local affiliate is PV Audit and Inspection-ready: -Act as the Astellas ‘Subject Matter Expert (SME)’-Support project management related to regulatory authority, business partner or internal inspections.-Acts as the main point of contact in absence of DSO, and as such, coordinates regulatory authority inspections in collaboration with QA and PV. + Contribute to the process of qualification of PV vendors. + Manage outsourced partners to ensure PV activities are conducted according to the relevant procedures and contractual agreements, as applicable. + Maintain contracts with Vendors and License Partners: subject to language ability. + Coordinate and perform activities related to the Quality Management System (QMS). + Coordinate/support the development and maintenance of locally applicable PV Procedural Documents (PD). + Request to have access to, and be aware of, the local affiliate business continuity plan (BCP) (e.g., system failures and other disasters) in relation to PV activities. + Responsible for ensuring a local mechanism is in place for 24/7availability to enable appropriate handling of potential urgent safety issues by the local affiliate, if applicable. + Contribute to the oversight and monitoring of all local studies and projects, including digital media and Astellas sponsored websites that impacts PV. + Provide input on behalf of PV regarding the development of safety monitoring and reporting plans for clinical trials that impact the local affiliate. Ensure local post-marketing programs (e.g., Post Authorization Studies [PAS], Post Authorization Programs [PAP] or market research, post marketing surveillance [PMS]) protocols are reviewed for compliance with PV requirements, as applicable. + Support the implementation of local activities concerning risk management and risk minimization, as applicable. + Ensure local initiatives such as company sponsored websites and other digital media, registries, and marketing initiatives are reviewed for compliance with PV requirements and Astellas PV procedures. **People and Organizational Management** Coordinate/support the development and maintenance of effective collaborations and communications with: + PV-HQ functions, PV AFM Function, M&D and non-M&D functions of the local affiliate. + Together with US DSO, serve as the point of contact for other(non) M&D functions at the local affiliate (e.g., Sales, Marketing, Health Systems, Communications, RA, MA, QA, etc.) + Liaise with PV AFM function and/or PV Business Partner Management function support the development of PV Agreements (PVAs) impacting the country/region. **Training** + Coordinates the development and execution and documentation of local PV Product Safety Awareness training to Affiliate (e.g., MI, Sales Reps, receptionists). Also, where applicable, to third party personnel providing PV-related services, and to other staff within the territory. **Qualifications Required:** + Minimum BA/BS degree (Pharmacy, Medical Degree, or Biomedical/Life Sciences), preferably with an advanced professional degree in Life sciences and/or MBA qualification. + Minimum of 5+ years relevant experience in PV or combined PV/RA/QA/clinical development. + Proactive involvement in external association activities (e.g., EFPIA) and networking to enhance knowledge and expertise. Maintain and build currency of expertise and promotes best practice, knowledge sharing and compliance. + Extensive experience with working through business partners/agents. + Sound knowledge of the PV landscape and associated procedures within the country/region, including Regional and Global PV requirements and global and regional directives. + Ability to influence at cross-functional peer level. + Track record of having successfully led and delivered (PV) projects. + Ability to coach and mentor junior personnel. + Take decisions with a pro-active and service-oriented attitude and demonstrate leadership to ensure local PV system and related activities at the local affiliate, including compliance are maintained at highest standards. + Ability to analyze and resolve complex situations. + 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 collaboration. + Proficiency in local language and business English language (written, verbal, presentation, facilitation). **Preferred:** + Project management experience (scope, interdependencies, budgeting, critical path analysis, reporting etc.) **Working Environment:** + At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. + This role is based in the US. + Limited (10% or less) travel expected. **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 \#LI-SS Category Affiliate Management Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans