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

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 integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

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