Job Title: Senior Manager – Patient Safety
Location: Andheri (East), Mumbai, India (Hybrid)
Company: Advanz Pharma
Employment Type: Full-Time
Company Overview:
Advanz Pharma is a global pharmaceutical company committed to improving patients’ lives by providing and enhancing specialty, hospital, and rare disease medicines. Headquartered in London, UK, with operations in over 20 countries, Advanz Pharma partners with innovative biopharma and pharmaceutical companies to bring essential medicines to patients worldwide. The Mumbai Centre of Excellence supports global operations, contributing to the commercialization of specialty and rare disease therapies across multiple markets.
Role Overview:
The Senior Manager, Patient Safety will oversee global and regional pharmacovigilance activities, focusing on Reference Safety Documents (CCDS, SmPC, PI, PIL, datasheets, and product monographs). The role ensures regulatory compliance, high-quality documentation, and alignment with global and regional processes. This position requires experience managing innovator drugs, branded generics, generics, and biosimilars.
Key Responsibilities:
Act as a subject matter expert in global labeling requirements and patient safety.
Manage and maintain Reference Safety Documents, ensuring compliance with applicable regulations and guidelines.
Supervise, review, and approve scientific documents including SmPCs, PILs, and datasheets.
Address Health Authority queries and support necessary submissions with appropriate data.
Plan, coordinate, and execute global labeling compliance activities across multiple regions.
Ensure Good Documentation Practices (GDP) and Pharmacovigilance compliance, coordinating with internal and external stakeholders.
Identify gaps in reference safety document management and lead improvement initiatives.
Support preparation and revision of SOPs and Work Instructions for consistency and compliance.
Stay updated on global pharmacovigilance requirements, including Rest of World territories.
Demonstrate leadership and accountability in a collaborative, entrepreneurial work environment.
Qualifications & Experience:
Post-graduate qualification in Life Sciences or Pharmacy.
Extensive experience in Patient Safety and management of Reference Safety Documents (CCDS, SmPC, PI, PIL).
Experience with innovator molecules and biosimilars.
Strong knowledge of end-to-end labeling, labeling management systems (e.g., Veeva Vault), and QRD templates from the EU.
Proven leadership, stakeholder management, and strategic planning skills.
Ability to work across global teams, multiple time zones, and diverse cultures.
Excellent communication, analytical, and problem-solving abilities.
Adaptable, proactive, and results-oriented mindset aligned with Advanz Pharma’s values: Entrepreneurship, Speed, and Integrity.
Why Advanz Pharma:
Join a global pharmaceutical leader committed to patient outcomes and innovation.
Thrive in an inclusive, agile, and entrepreneurial environment.
Flexible working options, competitive salary, and benefits package.
Opportunities for professional growth, internal promotion, and recognition through annual Impact Awards.
Culture that encourages gender equality and diversity, with nearly 40% of management roles held by women.
Application Process:
To apply, submit your CV and cover letter online. Advanz Pharma is committed to equal employment opportunities and fostering an inclusive workplace.
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