AdvanzPharma Hiring For Manager, Patient Safety

Responsibilities

• Act as subject matter expert for drafting, reviewing, and managing Safety Data Exchange Agreements (SDEAs) across all partner types.
• Lead negotiations, execution, and periodic reconciliation of SDEAs with co‑licensing, co‑development, distribution and local PV partners.
• Maintain an up‑to‑date SDEA tracker ensuring compliance with global and regional guidelines.
• Serve as primary point of contact for internal stakeholders and external partners on SDEA‑related queries.
• Oversee preparation, maintenance, review, quality control, approval and periodic update of global and regional Pharmacovigilance System Master Files (PSMFs).
• Ensure PSMF content is accurate, complete and aligned with applicable regulatory requirements (EU GVP, UK, US, etc.).
• Develop and implement inspection‑ready processes and documentation for PSMF and SDEA audits.
• Coordinate and support internal and external PV audits and regulatory inspections, providing required evidence and explanations.
• Design, maintain and continuously improve the annual Pharmacovigilance training program for global staff.
• Deliver GVP and PV training sessions to new joiners, senior staff and external partners, documenting attendance and competency.
• Monitor training compliance metrics, generate reports and initiate corrective actions for non‑compliance.
• Author, review and update Standard Operating Procedures (SOPs), Work Instructions (WIs) and templates related to PV, SDEA and PSMF activities.
• Conduct gap analyses of existing PV processes and implement process improvement initiatives.
• Stay current with evolving global PV regulations and industry best practices; translate changes into actionable updates.
• Collaborate with cross‑functional teams (clinical, regulatory, medical affairs, legal) to align PV activities with business objectives.
• Provide strategic input to senior management on PV risk mitigation and compliance strategies.
• Manage relationships with external service providers, CROs and contract vendors involved in safety data exchange.
• Prepare periodic PV performance dashboards for leadership review.
• Lead root‑cause investigations for safety data discrepancies and implement preventive measures.
• Ensure timely submission of safety reports (DSUR, PSUR, Periodic Safety Update Reports) as required.
• Oversee signal detection activities and coordinate follow‑up assessments.
• Contribute to the development of risk management plans and risk minimisation strategies.
• Participate in product launch safety planning and post‑marketing surveillance activities.
• Mentor junior PV staff and facilitate knowledge transfer within the team.
• Drive a culture of quality, compliance and continuous improvement across the PV function.
• Represent Advanz Pharma in external PV forums, workshops and regulatory meetings.
• Manage documentation archiving in accordance with retention policies and electronic systems.
• Conduct internal audits of PV processes and report findings to quality assurance.
• Support business continuity planning for PV operations during emergencies.
• Promote the company’s core values of entrepreneurship, speed and integrity in all PV activities.

Skills

• Pharmacovigilance regulations (EU GVP, UK, US FDA, ICH)
• Safety Data Exchange Agreements (SDEA) management
• Pharmacovigilance System Master File (PSMF) development
• GVP training design and delivery
• Audit and inspection readiness
• Risk management and signal detection
• Regulatory reporting (DSUR, PSUR, Periodic Safety Update)
• Cross‑functional stakeholder management
• Contract negotiation and vendor management
• SOP and WI authoring
• Data analysis and safety data interpretation
• Project management
• Change management
• Excellent written and oral communication
• Leadership and team mentoring
• Problem‑solving and root‑cause analysis
• Knowledge of rare disease medicines
• Familiarity with electronic PV systems (e.g., Argus, ArisGlobal, Veeva)
• Compliance monitoring and metrics reporting
• Strategic thinking and business acumen
• Ability to work in hybrid environment
• Proficiency in Microsoft Office Suite and data visualization tools
• Understanding of clinical trial safety processes
• Ability to influence senior management
• Time management and prioritisation
• Adaptability to fast‑changing regulatory landscape
• Ethical decision‑making
• Quality management systems (ISO 9001, GMP)
• Presentation and facilitation skills
• Knowledge of global health authority expectations

Company Overview

AdvanzPharma is a fast‑growing international pharmaceutical company headquartered in Mumbai, specializing in specialty, hospital and rare disease medicines. The company’s portfolio spans innovative biologics, small‑molecule therapies and biosimilars that address unmet medical needs across oncology, immunology and metabolic disorders. With a strong global presence in over 30 countries, AdvanzPharma is recognized for its rigorous scientific research, robust regulatory expertise and commitment to patient‑centric innovation. The organization offers accelerated career growth through structured learning programs, cross‑functional rotations and mentorship from industry leaders. Employees benefit from a collaborative culture that values entrepreneurship, speed and integrity, providing ample opportunities to contribute to life‑changing therapies while advancing personal professional development. AdvanzPharma’s reputation for compliance excellence, strategic partnerships and market expansion makes it an attractive employer for ambitious pharma professionals.

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