PV Affiliates Operations Professional
📍 Location: Bengaluru, India
🆔 Job ID: #1739
🏢 Company: Astellas Pharma Inc.
💼 Type: Full-time
Purpose and Scope
The PV Affiliates Operations Professional plays a key role in fostering a Culture of Quality within the Regulatory Pharmacovigilance (RAPV) Quality & Compliance function and Astellas PV Affiliate teams, ensuring compliance with global regulatory standards and protecting patient safety.
Key Responsibilities
1. Quality, Oversight, and Compliance Management
Support compliance activities in alignment with regulatory requirements and Astellas SOPs.
Maintain oversight over compliance-relevant aspects such as ICSRs, CAPAs, training, and quality systems.
Identify and mitigate compliance issues, ensuring appropriate Corrective and Preventive Actions (CAPAs).
Perform Root Cause Analysis (RCA) and trend analysis for compliance issues (e.g., late ICSR submissions).
Provide input to the Pharmacovigilance System Master File (PSMF) as requested.
Represent RAPV Q&C during audits and inspections (on-site or remote).
Support inspection-readiness and manage CAPA development from initiation to completion.
2. Project Management
Lead or contribute to cross-functional RAPV projects.
Define project strategy, manage activities, and ensure timely, high-quality, and cost-effective delivery.
Coach and guide junior colleagues during project execution.
Maintain audit/inspection-ready documentation and procedural compliance.
3. Procedural Document Management
Develop, review, and maintain RAPV-related procedural documents (PDs).
Ensure consistency and compliance across Q&C, Affiliate, and HQ-related PDs.
4. Relationship Management
Serve as a Point of Contact for RAPV Q&C, RAPV HQ, Affiliate teams, EU QPPV, and other non-RAPV functions.
Support due diligence activities for new product acquisitions, divestments, and licensing agreements.
Collaborate with Business Partner Management, Procurement, and other teams to maintain PV-related agreements (e.g., MSAs, PVAs).
Ensure effective communication across cross-functional PV teams, vendors, and partners.
5. Training and Mentoring
Provide PV training to internal teams, vendors, and third parties.
Act as a mentor/coach for junior colleagues, promoting continuous learning and quality awareness.
Required Qualifications
Education: Bachelor’s or Master’s degree in Health Science, Life Science, or Medical Science (or equivalent experience).
Experience: Minimum 7 years in Pharmacovigilance or related areas.
In-depth understanding of PV systems, compliance, and regulatory expectations.
Strong communication, influencing, and cross-cultural collaboration skills.
Proficient in Microsoft Office (Excel, Word, PowerPoint, Teams; knowledge of formulas/macros preferred).
Demonstrated organizational, analytical, and problem-solving abilities.
Fluent in English (written and verbal).
Willingness to travel as required.
Preferred Qualifications
Fluency in an additional language.
Knowledge of Project Management methodologies and tools.
Working Environment
Part of Astellas Global Capability Centres (GCCs) located in India, Poland, and Mexico.
GCCs serve as strategic hubs enhancing operational efficiency, innovation, and global collaboration.
Integral to Astellas’ mission of transforming innovative science into value for patients.
⚠️ Note on Recruitment
Beware of recruitment scams impersonating Astellas representatives. Authentic communication will only come from an official Astellas LinkedIn profile or verified company email. Report suspicious activity to LinkedIn Help immediately.
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