Pv Affiliates Operations Professional

Purpose and Scope:
The purpose of this role is to drive a Culture of Quality within the Regulatory Pharmacovigilance (RAPV) Quality and Compliance function as well as with the Astellas PV Affiliate teams

Responsibilities and Accountabilities:
Quality, Oversight and Compliance Management
- Support compliance activities in alignment with regulatory requirements and Astellas procedures to maintain Astellas’ reputation and protect patient safety by mitigation & escalation of identified issues/risks and take corrective and/or preventive actions, as required.
- Ensure oversight over compliance-relevant aspects like, but not limited to ICSRs, quality, training, CAPAs, and procedures.
- Pro-actively identify and drive, in close cooperation with, (non) RAPV Q&C colleagues and Affiliate staff actions to improve quality, compliance, processes and efficiency (resulting from compliance failures).
- Perform root cause analysis (RCA) for identified issues and identify the need for CAPAs

(global/regional/local Affiliate). Perform trend analysis on the identified issues and propose targeted actions.
- Perform RCA pertaining to ICSRs submitted late to Health Authorities, CROs and Business Partners.
- Support/provide input to the PSMF, as requested.
- Represent RAPV Q&C in Audits and Inspections (on-site and/or remote), as required.
- Support RAPV colleagues and PV Affiliate staff, before, during and after, HQ Inspections, local Affiliate Audits, license partners audits and local HA PV inspections.
- Identify and drive audit and Inspection-readiness activities.Support/execute the development of CAPAs (global/regional/local) from initiation to completion.

Project(s)
- Lead or participate in (cross functional) RAPV projects.
- If leading a project, define the strategy for optimal output and manage activities and team members to ensure that projects are timely completed, on budget and with high quality.
- Coach a (junior) colleague during the initiation, execution, and completion of RAPV projects.
- Ensure that project related processes, procedures and documents are in an up-to-date state and archived

(“Audit/Inspection ready”).

Procedural Documents

Drive/support the development, review and maintenance of RAPV (Q&C, Affiliate and HQ related) PDs and ensure consistency.

Relationship Management
- Act as a Point of Contact for and work with stakeholders within RAPV Q&C, RAPV HQ functions, RAPV Affiliate teams, EU QPPV and non-RAPV functions for topics related to quality and compliance that impact RAPV activities.
- Support RAPV and non-RAPV functions in due diligence activities of potential new product acquisitions /divestments / local country licensing agreements, if applicable.
- Support Business Partner Management (BPM), Procurement or other functions for the maintenance of contractual arrangements (e.g., Master Service Agreements (MSA) or PV Agreements (PVAs)).Maintain timely and effective communications among cross-functional PV team members, vendors, and business partners.

Training
- Provide training to RAPV and non-RAPV colleagues, vendors, and other 3rd parties, as required.Act as a mentor/coach for other (junior) colleagues

Required Qualifications:

- Degree in Health Science, Life Science, Medical Science or equivalent by experience (BS/MSc degree or equivalent).
- At least seven (7) years’ experience within PV or equivalent.
- A technical expert with an in-depth understanding of all PV aspects, related disciplines, a strong industry perspective and understanding of local requirements.
- Excellent communication and influencing skills to deal with cultural sensitivities and to influence and motivate others.
- Demonstrate tactfulness, diplomacy and a global mindset.
- Work independently and provide supervision to junior colleagues.
- Service orientated and pro-active problem-solving attitude.
- Excellent organizational skills, logical in thought and detail focused.
- Ability to work on multiple priority activities.
- Demonstrate proactive innovative, developing skills and continuously looks for improvement opportunities.
- Excellent verbal and written English language skills.
- Excellent understanding of good documentation practices.
- Ability to work with (company) required IT systems. Microsoft office (excel, word, PowerPoint, TEAMS), including usage of formulas and macros.Willingness to travel.

Preferred Qualifications:

- Fluency in an additional language.Project Management knowledge.

**Working Environment**

**Astellas’ Global Capability Centres - Overview**
- Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. _Our three GCCs are located in India, Poland and Mexico.- The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.- Our GCCs are an integ