PV Affiliates Operations Professional – Structured Format
Job ID: 1739
Location: Bengaluru, India
1. Purpose & Scope
Drive a Culture of Quality within:
Regulatory Pharmacovigilance (RAPV) Quality & Compliance (Q&C)
Astellas PV Affiliate teams
Ensure compliance, oversight, quality improvements, and operational excellence across PV affiliate operations.
2. Responsibilities & Accountabilities
A. Quality, Oversight & Compliance Management
Support compliance activities as per regulatory requirements and Astellas procedures to protect patient safety.
Ensure oversight of compliance-related activities including:
ICSR quality
Training
CAPAs
Procedures
Identify risks, mitigate issues, and implement corrective/preventive actions (CAPAs).
Perform Root Cause Analysis (RCA):
Compliance failures
Late ICSR submissions to HAs/CROs/business partners
Conduct trend analysis and propose targeted improvements.
Contribute inputs to the PSMF.
Represent RAPV Q&C during:
Audits
Health Authority inspections
License partner audits
Support Affiliate PV teams before, during, and after audits/inspections.
Ensure audit/inspection readiness across processes.
Lead/support CAPA development from initiation to closure.
B. Projects
Lead or participate in cross-functional RAPV projects.
When leading:
Define project strategy
Guide team members
Ensure timely, quality, and budget-efficient execution
Coach/mentor junior colleagues through project phases.
Maintain project-related documents in an audit-ready state.
C. Procedural Documents
Develop, review, and maintain RAPV Quality & Compliance SOPs.
Ensure consistency across RAPV HQ, Affiliate, and Q&C procedural documents.
D. Relationship Management
Act as a key point-of-contact for:
RAPV Q&C
RAPV HQ
PV Affiliate teams
EU QPPV
Non-RAPV functions
Support due diligence for product acquisitions/divestments/licensing.
Collaborate with BPM, Procurement, and other functions on MSAs and PV Agreements.
Maintain effective communication with cross-functional teams, vendors, and partners.
E. Training
Provide training to:
RAPV colleagues
Affiliate teams
Vendors and 3rd parties
Mentor junior team members.
3. Required Qualifications
Degree in Health Science/Life Science/Medical Science (BS/MSc or equivalent).
Minimum 7 years of experience in Pharmacovigilance (PV).
In-depth expertise in all PV areas and global/local regulatory requirements.
Excellent communication, influencing abilities, and cultural sensitivity.
Ability to work independently and supervise junior staff.
Strong problem-solving and organizational skills.
Good documentation practices.
Strong in MS Office: Excel (including formulas/macros), Word, PowerPoint, Teams.
Ability to manage multiple priorities.
Willingness to travel.
4. Preferred Qualifications
Fluency in an additional language.
Project management knowledge/skills.
5. Working Environment
Role is within Astellas Global Capability Centre (GCC).
GCCs support strategic global operations and drive innovation across:
India
Poland
Mexico
Work culture is collaborative, quality-focused, and supports global PV excellence.
6. Important Note
Beware of recruitment scams.
Authentic communication only comes from verified Astellas emails or official LinkedIn profiles.
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China | Quarry Bay |Hubei :
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Canada |Ontario :
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