Title: Deputy Manager – Quality PV
Location: Kurla, Mumbai, Maharashtra, India
Company: Piramal Critical Care (a division of Piramal Pharma Limited)
Department: Pharmacovigilance
Travel Required: No
Reports to: Head of Pharmacovigilance
Date: [Assumed April 30, 2025 – update if different]
Job Purpose:
To manage and oversee key Pharmacovigilance (PV) quality functions including the preparation of Pharmacovigilance System Master Files (PSMF), handling Safety Data Exchange Agreements (SDEAs), and coordinating with vendors and global partners to ensure compliance with regulatory standards.
Essential Qualifications:
Bachelor’s or Master’s degree in Pharmacy
Relevant Experience:
5–8 years of experience in Pharmacovigilance
Expertise in:
Pharmacovigilance System Master File (PSMF) management
Safety Data Exchange Agreements (SDEAs)
Vendor management and compliance documentation
Key Roles & Responsibilities:
Prepare and manage the PSMF/Summary of Pharmacovigilance System (SPS) for approval and submission.
Manage global Safety Data Exchange Agreements with business partners and distributors.
Conduct periodic data reconciliation with partners and stakeholders.
Oversee vendors managing local PV activities in Europe.
Coordinate with internal teams for distributor management and compliance.
Support internal, external, and regulatory PV audits and inspections.
Prepare and distribute PV compliance monitoring documents and data.
Provide compliance reports to the QPPV.
Assist with handling product complaints and reconciliation processes.
Collaborate with cross-functional teams for PV-related data requests and responsibilities.
Competencies:
Strong verbal and written communication skills
Effective interpersonal and collaboration skills
Time management and multi-tasking ability
High attention to detail with a commitment to meeting deadlines
Self-starter, capable of independent and team-based work
Proficient in Microsoft Word, Excel, and PowerPoint
About the Team:
Piramal Critical Care (PCC) is a global leader in hospital generics, known for its Inhaled Anaesthetics and Intrathecal Baclofen therapy. With operations in over 100 countries, PCC operates through world-class facilities in India and the U.S., regulated by US FDA, UK MHRA, and other global health authorities.
Equal Employment Opportunity:
Piramal Group provides equal employment opportunities to all individuals, regardless of race, religion, gender, disability, veteran status, or other protected characteristics. Employment decisions are based on merit, qualifications, and performance.
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