Associate Director, Pharmacovigilance Processes
Company: AstraZeneca
Location: Bangalore, India
Global Career Level: E
Job Type: Full-time
Application Deadline: April 1, 2025
Introduction to Role:
AstraZeneca is seeking an Associate Director, Pharmacovigilance Processes to work closely with the PV Processes Manager, Associate Director, and Director. This role involves managing AstraZeneca’s assigned projects and processes, ensuring compliance, performance, and inspection readiness. The successful candidate will contribute to the development of process strategies and oversee governance and management of procedural documents.
Key Accountabilities:
Identify and drive enhancements in existing processes using internal and external knowledge.
Develop, monitor, and assess global KPIs related to safety and regulatory data reporting.
Lead process updates in Patient Safety, including content updates, addressing comments, and document release.
Serve as an expert in ECMS tools and associated processes.
Support PS Process owners with guidance and compliance on PD processes.
Maintain and support the global inspection readiness strategy.
Provide process and compliance support to regulatory teams using deep pharmacovigilance knowledge.
Foster a culture of continuous improvement, innovation, and high performance.
Manage and oversee the Pharmacovigilance Quality System.
Handle lifecycle management of nominated processes to ensure compliance and business continuity. Monitor, analyze, and validate changing legislation and assess impact.
Participate in GVP, GCP, GRP, and GMP audits/inspections.
Lead global cross-functional task forces and deliver project assignments.
Conduct process training for relevant functional groups.
Build and maintain relationships with stakeholders and customers to support pharmacovigilance activities.
Essential Skills/Experience:
Science/Pharmacy/Nursing degree with at least 5 years of relevant experience in pharmaceutical, regulatory, safety, and partnerships.
Proven experience working cross-functionally and leading project teams.
Thorough scientific knowledge of regulatory/pharmacovigilance and partnerships.
Strong understanding of the drug development process.
Excellent attention to detail, communication, and collaboration skills.
Strong negotiation, conflict management, and interpersonal skills.
Ability to influence while maintaining independence and objectivity.
Understanding of change management processes.
Desirable Skills/Experience:
MSC/PhD in a scientific field.
Knowledge of new and developing regulatory and pharmacovigilance expectations.
Understanding of CoE and CMO operating models.
Experience working with third-party suppliers and external alliances.
Experience in a global pharmaceutical organization with knowledge of the drug development lifecycle.
Why Join AstraZeneca?
At AstraZeneca, innovation drives everything. Our commitment to Oncology aims to eliminate cancer as a cause of death. With an ambitious pipeline of high-quality molecules, we aim to deliver six new molecular entities by 2025. Our collaborative, dynamic environment encourages courage, curiosity, and empowerment, ensuring that every team member makes a difference.
Equal Opportunity Statement:
AstraZeneca is committed to building an inclusive and diverse team, ensuring equal opportunities for all applicants. We adhere to applicable non-discrimination laws and regulations, ensuring work authorization and employment eligibility compliance.
Date Posted: March 17, 2025
Closing Date: March 31, 2025
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