Position Title: PV Affiliates Operations Professional
Job ID: #1739
Location: Bengaluru, India
Employment Type: Full-time
About Astellas Pharma
Astellas Pharma Inc. is a global pharmaceutical leader operating in more than 70 countries worldwide, committed to turning innovative science into life-changing medical solutions. We focus on addressing unmet medical needs with ethics and integrity, improving the health and quality of life of patients everywhere.
🌐 Website: www.astellas.com
About Astellas Global Capability Centres (GCCs)
Astellas’ Global Capability Centres (GCCs)—located in India, Poland, and Mexico—enable access to world-class talent, operational efficiency, and innovation. These GCCs serve as integral extensions of Astellas’ core business, enhancing resilience, agility, and the ability to transform scientific advancements into VALUE for patients.
Purpose and Scope
The PV Affiliates Operations Professional is responsible for driving a Culture of Quality within the Regulatory Pharmacovigilance (RAPV) Quality & Compliance function, as well as across Astellas PV Affiliate teams.
This role ensures compliance with regulatory standards, promotes inspection readiness, and enhances the effectiveness and consistency of pharmacovigilance operations globally.
Key Responsibilities and Accountabilities
1. Quality, Oversight & Compliance Management
Ensure compliance with global and local PV regulations and Astellas procedures.
Support mitigation and escalation of identified compliance issues/risks, ensuring timely Corrective and Preventive Actions (CAPAs).
Provide oversight on compliance-related activities including ICSRs, training, CAPAs, procedures, and documentation.
Perform Root Cause Analyses (RCA) for identified issues, including late ICSR submissions to Health Authorities, CROs, and Business Partners.
Conduct trend analyses and propose targeted quality improvement actions.
Support and contribute to the Pharmacovigilance System Master File (PSMF).
Represent RAPV Q&C during audits and inspections (on-site and remote).
Support internal teams and affiliates before, during, and after audits/inspections.
Lead or support audit readiness activities and ensure inspection preparedness.
Manage and track CAPAs from initiation through completion.
2. Projects
Lead or participate in cross-functional RAPV projects to enhance compliance and efficiency.
Define strategies for project delivery within timelines, quality, and budget constraints.
Coach and guide junior colleagues in project execution.
Ensure all project documentation is up-to-date, archived, and inspection-ready.
3. Procedural Documents
Develop, review, and maintain RAPV-related procedural documents (PDs) for both Q&C and affiliate operations.
Ensure document consistency and compliance with global standards.
4. Relationship Management
Act as a primary point of contact for RAPV Q&C, HQ, Affiliate teams, and other internal/external stakeholders.
Support due diligence activities related to acquisitions, divestments, and licensing agreements.
Collaborate with Business Partner Management (BPM), Procurement, and other departments for maintaining PV Agreements (PVAs) and Master Service Agreements (MSAs).
Maintain effective communication between PV teams, vendors, and business partners.
5. Training & Mentorship
Deliver PV and compliance training to internal and external teams as required.
Act as a mentor and coach to junior team members, fostering professional development and excellence.
Required Qualifications
Degree in Health, Life, or Medical Sciences (BS/MSc or equivalent).
Minimum 7 years of experience in Pharmacovigilance (PV) or a related discipline.
In-depth understanding of global PV regulations, compliance frameworks, and quality systems.
Excellent communication, influencing, and interpersonal skills across cultural boundaries.
Strong ability to analyze data, perform RCA, and manage CAPAs.
Proficiency in Microsoft Office tools (Excel, Word, PowerPoint, Teams)—including formulas and macros.
Strong organizational and multitasking skills, with attention to detail.
Proven ability to work independently and supervise junior staff.
Fluency in English (written and verbal).
Willingness to travel internationally, as required.
Preferred Qualifications
Fluency in an additional language.
Project management knowledge and experience leading cross-functional initiatives.
Working Environment
Astellas’ GCCs are collaborative and dynamic workplaces that integrate technology, innovation, and scientific excellence. The Bengaluru GCC plays a pivotal role in pharmacovigilance quality, regulatory support, and operational optimization, fostering a culture of continuous improvement and compliance excellence.
⚠️ Important Notice
Beware of fraudulent job postings impersonating Astellas recruiters.
Authentic communications will only originate from official Astellas email addresses or verified LinkedIn profiles.
If you encounter suspicious profiles or messages, report them to LinkedIn Help immediately.
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